Biosimilars/News

EC approves first monoclonal antibody biosimilar

Biosimilars/News | Posted 13/09/2013

Hospira announced on 10 September 2013 that it had received European Commission (EC) approval for its biosimilar monoclonal antibody infliximab (Inflectra), a first in Europe.

Biocad signs deal for biosimilar darbepoetin alpha in Turkey

Biosimilars/News | Posted 06/09/2013

Russian biosimilars manufacturer Biocad has signed a definitive agreement with Turkish oncology specialist Koçak Farma for the export of biosimilar darbepoetin alpha active pharmaceutical ingredients (APIs).

Amgen to start phase III trial for biosimilar adalimumab

Biosimilars/News | Posted 27/09/2013

Biotechnology giant Amgen is to start a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from severe rheumatoid arthritis according to the EU Clinical Trials Register.

EMA approves biosimilar follitropin alfa and somatropin

Biosimilars/News | Posted 20/09/2013

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 31July 2013 that it had recommended granting of marketing authorization for a biosimilar follitropin alfa. While on 9 September 2013, the agency announced the approval of a new somatropin biosimilar.

Failed biosimilars company to be sold

Biosimilars/News | Posted 20/09/2013

The assets of biosimilars developer Elona Biotechnologies (Elona) will be auctioned on 27 September 2013 unless sold before 6 September 2013.

Celltrion applies for biosimilar infliximab approval in Japan

Biosimilars/News | Posted 13/09/2013

On 11 September 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of Remsima, its biosimilar infliximab monoclonal antibody, with Japan’s Ministry of Health, Labour and Welfare (MHLW).

Baxter and Coherus to collaborate on biosimilars

Biosimilars/News | Posted 06/09/2013

Baxter International (Baxter) has made another agreement for biosimilars, this time with fledgling biotech company Coherus Biosciences (Coherus).

Roche abandons Herceptin patent in India

Biosimilars/News | Posted 30/08/2013

Swiss-based pharma giant Roche has decided not to pursue its patent for its blockbuster cancer drug Herceptin (trastuzumab) in India, opening the market to biosimilars.

Indian firms chasing ‘similar biologic’ Herceptin

Biosimilars/News | Posted 30/08/2013

Following the decision by Swiss-based pharma giant Roche not to pursue its patent for Herceptin (trastuzumab) in India [1] it seems that a whole host of Indian firms are lining up to get their ‘similar biologic’ of the blockbuster cancer drug to market.

Apotex breaking into the North American and European G-CSF markets

Biosimilars/News | Posted 23/08/2013

A new biosimilar filgrastim is poised to enter the important granulocyte colony-stimulating factor (G-CSF) market following a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP).

EMA approval for Teva’s long-acting recombinant G-CSF

Biosimilars/News | Posted 23/08/2013

The European Medicines Agency (EMA) has granted marketing authorization for a new long-acting filgrastim – Lonquex (XM22 lipegfilgrastim) – to prevent chemotherapy-induced neutropenia in cancer patients.

AstraZeneca pursuing biosimilars with Celltrion bid

Biosimilars/News | Posted 16/08/2013

Pharma giant AstraZeneca is rumoured to be ready to join the race for biosimilars with a bid for South Korean biotechnology company Celltrion.

Teva and Lonza end biosimilars agreement

Biosimilars/News | Posted 09/08/2013

Despite Switzerland-based API producer Lonza denying reports back in April 2013 that it was considering backing out of its biosimilars joint venture with Israeli generics giant Teva Pharmaceutical Industries (Teva) that is just what has happened.

EMA reviewing biosimilar insulin application

Biosimilars/News | Posted 02/08/2013

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released on 4 July 2013 the agency is now reviewing a new application for a biosimilar insulin product.

Biosimilar G-CSF prescribed more than originator

Biosimilars/News | Posted 02/08/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 22 July 2013 that its biosimilar granulocyte colony-stimulating factor (G-CSF) Zarzio (filgrastim) has overtaken the originator product in terms of prescriptions.

Sandoz to start phase III etanercept trial

Biosimilars/News | Posted 24/05/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, is to start a phase III clinical trial for a biosimilar version of etanercept in patients suffering from psoriasis, according to the EU Clinical Trials Register.

Pfizer to start trial for biosimilar adalimumab

Biosimilars/News | Posted 21/06/2013

Pharma giant Pfizer is once again expanding its pipeline of biosimilars and is set to start a phase I study for its biosimilar adalimumab candidate (PF-06410293) according to ClinicalTrials.gov, the US clinical trials website.

Sandoz comments on EMA’s new draft biosimilars guidance

Biosimilars/News | Posted 21/06/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, is pleased that the European Medicines Agency (EMA) has issued a draft revised guideline on non-clinical and clinical issues in biosimilar product development.

Celltrion applies for Korean approval of biosimilar trastuzumab

Biosimilars/News | Posted 07/06/2013

On 4 June 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of its biosimilar candidate CT-P6 with the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Russia to harmonize biologicals regulations

Biosimilars/News | Posted 31/05/2013

International regulatory bodies and the drug industry met in Moscow on 15 May 2013 to discuss how to harmonize Russia’s regulatory standards for biologicals with the rest of the world to develop a framework for pharma companies developing biologicals and biosimilars in Russia.

Huahai and Oncobiologics make biosimilars deal

Biosimilars/News | Posted 24/05/2013

US-based Oncobiologics announced on 8 May 2013 that it had signed an alliance agreement for the development, manufacture and commercialization of biosimilar monoclonal antibodies with Zhejiang Huahai Pharmaceutical (Huahai).

Agila Biotech and Pfenex make biosimilars deal

Biosimilars/News | Posted 17/05/2013

Agila Biotech, a subsidiary of India-based Strides Arcolab, and US-based biotech firm Pfenex announced on 16 April 2013 that they had entered into a joint venture for biosimilars.

Sanofi starts biosimilar insulin trials

Biosimilars/News | Posted 10/05/2013

Pharma giant Sanofi confirmed in its 2013 Q1 business report that its biosimilar insulin projects have entered into phase I of clinical development as planned. Sanofi intends to develop these insulin products in order to further enlarge the Sanofi diabetes portfolio and better serve the needs of people with diabetes.

Intas launches rituximab ‘similar biologic’ in India

Biosimilars/News | Posted 10/05/2013

India-based generics company Intas Pharmaceuticals (Intas) announced the launch of a ‘similar biologic’ – as the Indian regulatory authorities call these products –version of rituximab in India.

Sandoz applies for Japanese approval for biosimilar G-CSF

Biosimilars/News | Posted 03/05/2013

Novartis generics unit Sandoz announced on 25 April 2013 that it has filed an application with the Japanese health authority – Pharmaceuticals and Medical Devices Agency (PMDA) – for marketing authorization of EP2006, a biosimilar version of recombinant human granulocyte colony-stimulating factor (G-CSF).

Biosimilars agreements for Hospira and mAbxience

Biosimilars/News | Posted 03/05/2013

In line with Hospira’s strategy of expansion into biosimilars, the injectable generics specialist announced on 29 April 2013 that it had entered into a collaborative arrangement for several biosimilar products with NovaQuest Co-Investment Fund I, L.P. (NovaQuest).

Hospira marks five years of biosimilars

Biosimilars/News | Posted 29/04/2013

Self-proclaimed world leader in injectable drugs, Hospira, commemorated five years of providing biosimilars to the European market at the BIO International Convention in Chicago, USA, on 24 April 2013.

Celltrion stops phase III trial of biosimilar rituximab

Biosimilars/News | Posted 29/04/2013

South Korean biotechnology company Celltrion has stopped the late-stage trial of its biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

Cipla launches first etanercept ‘similar biologic’ in India

Biosimilars/News | Posted 19/04/2013

India-based generics manufacturer Cipla announced on 17 April 2013 the launch of its ‘similar biologic’ product Etacept, the first ‘similar biologic’ of etanercept in India.

Lonza not backing out on biosimilars

Biosimilars/News | Posted 12/04/2013

Lonza has made a statement refuting reports that the Switzerland-based company was considering backing out of its biosimilars joint venture with Israeli generics giant Teva Pharmaceutical Industries (Teva).

Amgen’s biosimilar plans

Biosimilars/News | Posted 05/04/2013

Amgen was one of the first companies to recognize the potential of modern biotechnology and this has made it the world’s largest independent biotechnology firm.

Lonza/Teva biosimilar pact in jeopardy

Biosimilars/News | Posted 05/04/2013

Switzerland-based API producer and custom manufacturing organization Lonza is reviewing whether it is still worth investing in its joint venture for biosimilars with Israeli generics giant Teva Pharmaceutical Industries (Teva).

Sandoz’s biosimilar rituximab on track

Biosimilars/News | Posted 29/03/2013

The development of a biosimilar version of Rituxan (rituximab) is proceeding as planned, Sandoz’s Global Head, Mr Jeff George told Bloomberg.

When will the US biosimilars pathway be used

Biosimilars/News | Posted 22/03/2013

FDA Commissioner Margaret Hamburg presented the latest statistics on the US biosimilar pathway during a speech at the Massachusetts Biotechnology Council’s (MassBio) Annual Meeting on 15 March 2013.

Greece says no to automatic substitution of biologicals

Biosimilars/News | Posted 15/03/2013

Greece’s Medicines Agency (National Organization for Medicines, Ethnikos Organismos Farmakon, EOF) released a document on 13 March 2013 recommending against automatic substitution/interchangeability of reference biologicals and their biosimilars.

Japan approves second biosimilar G-CSF

Biosimilars/News | Posted 08/03/2013

Japan has granted regulatory approval to a second biosimilar granulocyte colony-stimulating factor (G-CSF).

XBiotech moves into biosimilars

Biosimilars/News | Posted 08/03/2013

US-based biotech company XBiotech announced on 26 February 2013 that the company would be expanding its portfolio to include biosimilars.

Mylan and Biocon to partner on insulin products

Biosimilars/News | Posted 01/03/2013

Generics giant Mylan announced on 13 February 2013 that it had entered into an agreement with India-based Biocon to develop and market Biocon’s biosimilar versions of three insulin analogue products.

Oncobiologics and Viropro make biosimilar deal

Biosimilars/News | Posted 01/03/2013

US-based Oncobiologics and monoclonal antibody developer Viropro announced on 25 February 2013 that they had signed a biosimilar collaboration agreement between the two companies.

Production of 24 biogeneric products in Iran by 2012

Biosimilars/News | Posted 03/02/2012

According to reports on Iran’s English-language television network, Press TV, Iran is making significant advances in biogeneric products and biotechnology drugs and is planning to start the production of 24 additional biogeneric products drugs by the end of 2012.

Amgen’s response to biosimilar substitution legislation in US

Biosimilars/News | Posted 22/02/2013

Amgen, in a statement issued on 1 February 2013, has hit back at accusations that the biotech giant is attempting to limit the uptake of biosimilars in the US by backing state bills, which constrain the use of biosimilars.

Merck makes biosimilars deal with Samsung Bioepis

Biosimilars/News | Posted 22/02/2013

Pharma Giant Merck announced on 20 February 2013 that it had made a deal to develop and commercialize biosimilars with Samsung Bioepis.

AMAC and GPhA hit back at Big Pharma over biosimilars

Biosimilars/News | Posted 15/02/2013

The Association of Mature American Citizens (AMAC) and the Generic Pharmaceutical Association (GPhA) have reacted strongly to the actions by Amgen and Genentech, which aim to make it more difficult for patients to get access to biosimilar medicines [1].

Biotech firms try to limit biosimilar substitution in US

Biosimilars/News | Posted 08/02/2013

FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the US.

China-based Innovent gains funding for expansion

Biosimilars/News | Posted 07/12/2012

Innovent Biologics (Innovent) has raised US$25 million in Series B financing to put towards the continued expansion of its pipeline and manufacturing capabilities.

Finox submits r-FSH biosimilar application to EMA

Biosimilars/News | Posted 18/01/2013

Finox Biotech announced on 20 December 2012 that it had submitted a Marketing Authorisation Application (MAA) for its biosimilar recombinant follicle stimulating hormone (r-FSH) to EMA on 30 October 2012.

ProCognia completes global glycoanalysis centre

Biosimilars/News | Posted 24/01/2013

Israeli biotech company ProCognia announced on 14 January 2013 the completion of its global centre of excellence for glycoanalytics.

Biosimilar trastuzumab made in tobacco plants

Biosimilars/News | Posted 18/01/2013

Canada-based PlantForm have altered tobacco plants to create a biosimilar version of Roche’s breast cancer drug Herceptin (trastuzumab).

CCM and Biocon make biosimilar insulin deal

Biosimilars/News | Posted 11/01/2013

Malaysia-based Chemical Company of Malaysia Berhad (CCM), announced on 14 December 2012 an agreement between its subsidiary, CCM Pharmaceuticals Sdn Bhd (CCMP), and India-based Biocon, giving CCMP exclusive licence and distribution rights to market, sell and distribute a range of insulin products in Malaysia and Brunei.

Marvel withdraws biosimilar insulin applications

Biosimilars/News | Posted 07/12/2012

EMA announced on 27 November 2012 that it had been informed by Marvel LifeSciences (Marvel) that the company would be withdrawing its authorization applications for its three biosimilar human insulins.

Approval of first biosimilar G-CSF in Japan

Biosimilars/News | Posted 30/11/2012

Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced on 21 November 2012 that they had gained approval for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.

Reliance Life Sciences starts ‘similar’ infliximab trial in India

Biosimilars/News | Posted 26/10/2012

Reliance Life Sciences is starting a clinical trial for a ‘similar biologic’ version of infliximab in patients suffering with rheumatoid arthritis in India.

STC Biologics receives US$2.5 million for biosimilar mAb development

Biosimilars/News | Posted 26/10/2012

US-based biotechnology company STC Biologics announced on 10 October 2012 that it had entered into a US$2.5 million phase II Small Business Innovation Research (SBIR) contract with the National Cancer Institute (NCI) to develop a STC101, a biosimilar monoclonal antibody (mAb), for the treatment of cancer.

Samsung halts biosimilar rituximab development

Biosimilars/News | Posted 19/10/2012

South Korean electronics giant Samsung has halted clinical development for the biosimilar version (SAIT101) of Roche’s Rituxan/MabThera (rituximab).

TNF copy biological approved in China

Biosimilars/News | Posted 20/05/2011

China-based Simcere Pharmaceutical Group (Simcere) announced on 9 May 2011 that Shanghai Celgen Bio-Pharmaceutical (Shanghai Celgen) has received approval for Qiangke – a copy biological version of etanercept – by the Chinese authorities.

Brazil to manufacture follow-on adalimumab

Biosimilars/News | Posted 13/05/2011

The Brazilian Ministry of Health (Ministério da Saúde) announced on 5 April 2011 that it would be entering into an agreement with PharmaPraxis to manufacture a biosimilar, or follow-on version, of Abbott’s monoclonal antibody Humira (adalimumab).

Medicago and Cellectis in successful biosimilars research collaboration

Biosimilars/News | Posted 19/10/2012

Canadian biopharmaceutical company Medicago and Cellectis plant sciences, a subsidiary of Cellectis SA, French genome engineering specialist, announced on 4 October 2012 the successful completion of the first step in their research collaboration to improve therapeutic proteins produced in tobacco plants.

Teva halts phase III biosimilar rituximab trial

Biosimilars/News | Posted 12/10/2012

Israeli generics giant Teva Pharmaceutical Industries (Teva) has suspended its phase III trial of its biosimilar version (TL011) of Roche’s Rituxan/MabThera (rituximab).

EMA receives second application for biosimilar infliximab

Biosimilars/News | Posted 05/10/2012

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in September 2012, the agency will be reviewing a second application for a biosimilar version of infliximab.

Bioton and Medipolis sign insulin analogue technology licensing agreement

Biosimilars/News | Posted 05/10/2012

Polish biotechnology company Bioton and Finnish-based contract research organisation (CRO) Medipolis GMP (Medipolis) have signed a licensing agreement on the manufacturing technology of an insulin analogue.

Roche does not see a threat from biosimilars until 2015

Biosimilars/News | Posted 21/09/2012

Switzerland-based drugmaker F. Hoffmann-La Roche (Roche) expects results from 19 late-stage clinical trials over the next 18 months to provide a stream of products to offset potential near-term threats to its cancer drugs Herceptin (trastuzumab) and Rituxan (rituximab).

Sun recalls biosimilar brain treatment

Biosimilars/News | Posted 21/09/2012

India-based Sun Pharmaceutical Industries (Sun Pharma) is once again in the news, but for the wrong reasons.

EMA reviews its first biosimilar monoclonal antibody

Biosimilars/News | Posted 27/04/2012

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in April 2012 the agency will be reviewing a new application for a biosimilar version of infliximab.

Teva receives FDA approval for filgrastim in the US

Biosimilars/News | Posted 14/09/2012

Teva Pharmaceutical Industries (Teva) announced on 30 August 2012 that FDA had granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the US in more than 10 years.

Dr Reddy’s plans EU launch for biosimilar rituximab

Biosimilars/News | Posted 14/09/2012

India-based generics drugmaker Dr Reddy’s Laboratories (Dr Reddy’s) is planning to launch its biosimilar monoclonal antibody Reditux (rituximab) in Europe.

Asian companies venture into biosimilars for kidney failure

Biosimilars/News | Posted 10/08/2012

Malaysia-based Chemical Company of Malaysia Berhad (CCM) wholly-owned subsidiary CCM Duopharma Biotech Berhad and Korea-based biotechnology company PanGen Biotech announced on 19 June 2012 that the companies had entered into an agreement to carry out a clinical trial of biosimilar erythropoietin in Malaysia to treat end stage renal failure patients.

iBio and GE Healthcare form new global alliance

Biosimilars/News | Posted 10/08/2012

Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, and GE Healthcare, the health business of General Electric, announced on 26 July 2012 a new global alliance to commercialise plant-based technologies for the manufacture of biologicals and vaccines.

Deal struck over development of Herceptin biosimilar

Biosimilars/News | Posted 03/08/2012

Netherlands-based biopharmaceutical company Synthon announced on 18 July 2012 that it has entered into a global licensing agreement with Amgen and Watson Pharmaceuticals for the clinical development and testing of biosimilar trastuzumab as an alternative to Roche’s blockbuster anticancer agent Herceptin. The deal follows the results of a phase I trial reported on 22 March 2012 showing bioequivalence between Synthon’s trastuzumab and Herceptin [1].

Biosimilar monoclonal antibody approved in Korea

Biosimilars/News | Posted 03/08/2012

South Korean biotechnology company Celltrion announced on 23 July 2012 that the Korean Food and Drug Administration (KFDA) had approved its first monoclonal antibody, Remsima.

Trials of biosimilar monoclonal antibody prove biosimilarity

Biosimilars/News | Posted 22/06/2012

South Korean biotechnology company Celltrion presented the PLANET clinical studies results of phase I and phase III trials for its first monoclonal antibody biosimilar (CT-P13) of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab) at the Annual Congress of the European League Against Rheumatism (EULAR) held in Berlin, Germany, on 6–9 June 2012. The results demonstrated the biosimilarity of CT-P13 to the reference drug, supporting the company’s intention to launch the biosimilar monoclonal antibody globally.

Amgen welcomes biosimilar monoclonal antibody guideline

Biosimilars/News | Posted 22/06/2012

In a statement issued on 18 June 2012, biologicals major Amgen announced that the company broadly supports the scientific principles behind the guideline on non-clinical and clinical aspects for biosimilar monoclonal antibodies recently issued by EMA [1]. The company added that the guideline aims at maintaining a high standard for approval of a biosimilar in the EU.

Successful phase III trial of biosimilar r-FSH

Biosimilars/News | Posted 18/06/2012

Finox Biotech announced on 6 June 2012 that the company’s pivotal phase III study with Afolia, a biosimilar recombinant follicle stimulating hormone (r-FSH), in patients undergoing assisted reproduction technology (ART), had met its primary endpoint.

Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs

Biosimilars/News | Posted 08/06/2012

Pharma major Merck KGaA announced on 6 June 2012 its first steps into the biosimilars market, with an agreement with India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) to co-develop biosimilar cancer drugs.

Alternative delivery devices for biosimilars

Biosimilars/News | Posted 01/06/2012

FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.

Daiichi Sankyo and Coherus BioSciences make biosimilars deal

Biosimilars/News | Posted 18/05/2012

Coherus BioSciences and Daiichi Sankyo announced on 7 May 2012 that the two companies had made an exclusive agreement to develop and commercialise biosimilars of etanercept and rituximab in certain Asian countries including Japan.

Bayer opposes sorafenib compulsory licence in India

Biosimilars/News | Posted 11/05/2012

German pharma giant Bayer told Reuters on 5 May 2012 it had challenged a decision by the Indian Government, which allows India-based generics firm Natco Pharma to sell a generic version of Bayer’s liver and kidney cancer drug Nexavar (sorafenib) in India, before its patent expires in 2020.

Abbott asks FDA to block adalimumab biosimilar

Biosimilars/News | Posted 04/05/2012

Abbott Laboratories (Abbott) submitted a 30-page citizen petition to FDA on 2 April 2012 asking the agency to reject any biosimilar for its rheumatoid arthritis drug Humira (adalimumab). Abbott says that FDA would be forced to use trade secrets included in Humira’s Biologics License Application (BLA) to approve biosimilars. Abbott is therefore requesting that FDA refuses to review any biosimilar biological whose BLA was submitted before the Biologic Price Competition and Innovation (BPCI) Act of 2009 came into effect on 23 March 2010.

Novartis versus the Indian patent system

Biosimilars/News | Posted 27/04/2012

The Indian patent system is once again under scrutiny as a final decision in the case of Novartis versus the Indian patent system is eagerly awaited by originator biologicals and biosimilars manufacturers alike. However, any decision on the case has been delayed until 10 July 2012.

Samsung to launch biosimilars by 2015 at half the current prices

Biosimilars/News | Posted 23/04/2012

South Korean electronics giant Samsung told the Financial Times that it plans to launch biosimilars by 2015 at half the prices that patients in Europe and the US currently pay.

Biocon opens new research centre

Biosimilars/News | Posted 23/04/2012

Indian biosimilars major Biocon, announced on 5 April 2012 the opening of a new state-of-the-art Integrated Research and Development Centre in Bangalore, India.

EMA publishes procedural advice for biosimilars

Biosimilars/News | Posted 13/04/2012

On 11 April 2012, EMA published a new document on regulatory procedural advice for biosimilars.

Fujifilm and Kyowa launch biosimilars joint venture

Biosimilars/News | Posted 30/03/2012

The Japanese digital camera maker Fujifilm Corporation (Fujifilm) and biotech firm Kyowa Hakko Kirin (Kyowa) announced on 27 March 2012 that they have launched their biosimilars joint venture, which will initially focus on the development of biosimilar adalimumab.

Dr Reddy’s looks to biosimilars for growth

Biosimilars/News | Posted 23/03/2012

Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) has been betting big on biosimilars and it seems that the risk is paying off, as the company announced record profits for the last quarter of 2011.

GE Healthcare expands biologicals business

Biosimilars/News | Posted 23/03/2012

GE Healthcare, the health business of General Electric, announced on 7 March 2012 that it had reached an agreement to acquire biologicals manufacturer Xcellerex.

European biosimilars market to reach almost US$4 billion by 2017

Biosimilars/News | Posted 09/03/2012

According to researchers at Frost & Sullivan, the European market for biosimilars will experience strong growth in the coming years due to patent expiries of blockbuster biologicals between 2010 and 2017. Cost containment strategies being implemented by governments and healthcare service providers are also given credit for shifting sales towards cheaper biosimilars.

Pfizer and Biocon’s biosimilar insulin deal is off

Biosimilars/News | Posted 16/03/2012

Pfizer, the world’s largest pharma company, and Indian biosimilars major Biocon announced on 12 March 2012 that they had decided to end their biosimilar insulin deal due to ‘differing priorities’.

Biosimilar alliance between Celerion and Ricerca

Biosimilars/News | Posted 09/03/2012

Contract research organisations (CROs) Celerion and Ricerca Biosciences announced on 29 February 2012 the formation of an integrated service solution for the development of biosimilar products.

FDA discusses biosimilars guidance

Biosimilars/News | Posted 02/03/2012

FDA issued its long-awaited guidance for biosimilar applications on 10 February 2012 in the form of three draft guidance documents [1]. In a webinar on 15 February 2012 FDA discussed some of the issues surrounding biosimilar products and expanded on some of the requirements contained within the guidance documents.

Regulation of biosimilars in the US

Biosimilars/News | Posted 24/02/2012

The US pharmaceutical industry plays a vital role in shaping the face of American health care. With major patent expiries and thin product pipelines, the industry is now considering new directions to maintain growth and stability. Biological drugs, derived from living organisms, represent a growing opportunity for big pharmaceutical firms. They command high prices, will probably have fewer firms making them than generics due to high barriers to entry, and play to the existing strengths of big pharma firms. But will the recent healthcare legislation provide the way for consistent FDA regulation? What is the most likely way in which biologicals will enter the market over the next few years?

Successful completion of biosimilar infliximab programme

Biosimilars/News | Posted 17/02/2012

South Korean biotechnology company Celltrion announced on 1 February 2012 the successful completion of the company’s clinical programme for its (CT-P13) biosimilar of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

Spinnovation enters biosimilar collaboration with Quantum Tessera

Biosimilars/News | Posted 10/02/2012

Dutch-based bioanalysis specialist Spinnovation Biologics (Spinnovation) announced on 24 January 2012 that it had entered into a collaboration with US-based consulting company Quantum Tessera.

Amphastar and Watson launch biosimilar enoxaparin

Biosimilars/News | Posted 03/02/2012

US generics manufacturer Watson Pharmaceuticals announced on 26 January 2012 that Amphastar Pharmaceuticals and Watson had been granted their request for a stay of the preliminary injunction preventing the companies from marketing or selling Amphastar’s enoxaparin sodium injection.

Sandoz starts phase III trials for biosimilar filgrastim and pegfilgrastim

Biosimilars/News | Posted 27/01/2012

On 19 January 2012, Sandoz, the generic drug division of Swiss drug giant Novartis AG, announced that it had started two phase III clinical trials, one for biosimilar filgrastim (Amgen’s Neupogen) for the US market and the other for its global pegfilgrastim (Amgen’s Neulasta) development programme.

Roche encounters manufacturing issues with epoetin-beta

Biosimilars/News | Posted 27/01/2012

The Spanish regulatory agency has found deviations in the quality of the manufacture of Switzerland-based F. Hoffmann-La Roche’s biological anaemia treatment Mircera (methoxy polyethylene glycol-epoetin beta), a long acting erythropoiesis-stimulating agent; and is recommending patients to change to other epoetins.

Baxter and Momenta make biosimilars deal

Biosimilars/News | Posted 20/01/2012

Baxter International (Baxter) and Momenta Pharmaceuticals (Momenta) announced on 22 December 2011 that they had entered into a global collaboration agreement to develop and commercialise biosimilars.

Amgen finally jumps on biosimilars bandwagon

Biosimilars/News | Posted 13/01/2012

Biotech giant Amgen and US generics manufacturer Watson Pharmaceuticals (Watson) announced on 19 December 2011 that the two companies had agreed to collaborate on the development and commercialisation of several cancer antibody biosimilars.

Hospira starts phase III programme for biosimilar erythropoietin

Biosimilars/News | Posted 13/01/2012

Hospira, self-proclaimed leader in injectable generics, announced on 9 January 2012 that the company had enrolled the first patient in its phase III programme in the US for its biosimilar erythropoietin (EPO).

First biosimilar G-CSF in Japan

Biosimilars/News | Posted 13/01/2012

Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced on 26 December 2011 that they had filed respective applications for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.

Samsung makes biosimilars deal with Biogen Idec

Biosimilars/News | Posted 16/12/2011

Korean electronics giant Samsung announced on 6 December 2011 that it had entered into a biosimilars joint venture with US biotechnology company Biogen Idec (Biogen).

Indian Transgene sells biosimilar to German TSS Export

Biosimilars/News | Posted 09/12/2011

India-based biotech company Transgene Biotek Limited (Transgene) announced on 24 November 2011 the sale of technology for biosimilar recombinant human erythropoietin (rh-EPO) to TSS Export GmbH FZE, part of the Germany-based TSS group, for US$5 million (Indian Rupees 260 million).

National Psoriasis Foundation declares biosimilar stance

Biosimilars/News | Posted 02/12/2011

One of the leading psoriasis patient associations in the US, the National Psoriasis Foundation, has publically declared its stance on biosimilars. In an open letter to FDA, the Foundation issued a statement on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009 [1].

Fujifilm and Kyowa Hakko Kirin in biosimilars joint venture

Biosimilars/News | Posted 02/12/2011

Japanese Fujifilm Corporation announced on 16 November 2011 that it is once again making an agreement in the biosimilars field, this time with biotech firm Kyowa Hakko Kirin, Tokyo, Japan.

New Amgen Enbrel patent could block biosimilars until 2028

Biosimilars/News | Posted 25/11/2011

Amgen announced on 22 November 2011 that it had been granted a new US patent on its blockbuster drug Enbrel (etanercept).

Acino grabs Cephalon’s Middle East and African business

Biosimilars/News | Posted 25/11/2011

Switzerland-based generics company Acino Pharma announced on 14 October 2011 that it had agreed to buy biopharmaceutical company Cephalon ’s combined Middle East and African business in a transaction worth approximately Euros 80 million.

Natco snaps up biosimilars: signing deal with Mabxience

Biosimilars/News | Posted 18/11/2011

Indian generic drugmaker Natco Pharma announced that it had entered into an exclusive agreement with Mabxience, the biosimilar division of Swiss firm Chemo Sa Lugano, on 19 September 2011.

Battle rages over anti-thrombotic medicine

Biosimilars/News | Posted 10/11/2011

Sandoz/Momenta are ahead again in the fight for the lucrative anticoagulants market in the US. According to IMS Health data enoxaparin sodium injection is the best-selling hospital medicine in the US, and has been described as the ‘gold standard’ for anti-thrombotic treatments. Lovenox, sanofi-aventis’ reference product, recorded US sales of US$2.7 billion in 2009 and has been used to treat an estimated 200 million patients worldwide since it was launched.

US$1 billion for cancer R & D

Biosimilars/News | Posted 04/11/2011

GE Healthcare, the health business of General Electric, provides advanced cancer diagnostic and molecular imaging capabilities, as well as technologies for the manufacture of biopharmaceuticals and for cancer research. Its presence at the European Multidisciplinary Cancer Congress 2011 in Stockholm indicated its commitment to strengthening cancer diagnosis and care. Similarly at the 53rd Annual American Society for Radiation Oncology Meeting in Miami Beach, Florida, USA, it was showcasing a number of new tools designed specifically for the needs of radiation oncologists.

FDA new drug approvals up in 2011: 900 biotech drugs in development

Biosimilars/News | Posted 07/10/2011

FDA had already approved 26 new drugs by the end of August 2011 compared to only 21 approved in 2010. Of note were six cancer drugs and two ground-breaking drugs for hepatitis C. The current year looks likely set a record for recent years for new drug approvals, which may total 35–40 by the end of 2011. After a slow start in the first two months with three new drug approvals and nine rejections in January and February 2011, FDA approved four new drugs, two of which were monoclonal antibodies, in March and five in April. Of the 11 new drugs approved in the first four months, only three biologicals were approved.

Biocon announces Malaysia manufacturing plant

Biosimilars/News | Posted 21/10/2011

Biocon, a global biopharmaceutical company with high-tech manufacturing and research arms, announced in September 2011 ‘project commencement for its first high-end biopharmaceutical manufacturing and R & D facility in Bio-XCell, Malaysia’ [1]. Malaysia, epitomised by the Bio-XCell biotechnology park, is considered ‘an ideal location to manufacture generics’ by industry analysts Frost & Sullivan.

Biosimilar user fees proposal under review

Biosimilars/News | Posted 21/10/2011

Proposals over biosimilar user fees appear to have been ratified by stakeholders and a proposal is now under review by the US Department of Health and Human Services.

Rituximab biosimilar successfully produced in plants

Biosimilars/News | Posted 21/10/2011

iBio, a leader in the plant-made pharmaceutical field, announced on 5 October 2011 that it had successfully expanded the use of its technology to biosimilar monoclonal antibodies (mAbs) by producing rituximab in non-transgenic green plants.

Cheap biosimilars to come from India and China

Biosimilars/News | Posted 21/10/2011

On 19-20 September 2011, the United Nations (UN) held a High-Level Meeting to develop a global strategy to fight non-communicable diseases, ‘principally cardiovascular diseases, cancers, chronic respiratory diseases and diabetes.’ It is only the second global health issue that the UN General Assembly has deemed urgent enough to call a meeting to discuss. Such diseases cause approximately two-thirds of all deaths.

A snapshot of interesting new approvals by FDA

Biosimilars/News | Posted 14/10/2011

New approvals by FDA look set reach record levels in 2011. Some noteworthy drugs already approved in 2011 are discussed below.

EMA plans to revise biosimilar guidelines

Biosimilars/News | Posted 07/10/2011

EMA announced on 3 October 2011 that it has published a concept paper asking for comments on topics to be included in a potential revision of the agency’s 2006 biosimilar guideline, which covers non-clinical and clinical development of biosimilars. The paper will be released for a 3-month consultation period.

Biosimilar user fee levels and performance goals for the FDA

Biosimilars/News | Posted 07/10/2011

FDA and representatives from the drug industry negotiating a user fee for biosimilars have tentatively set performance goals and biosimilar user fee levels, creating a separate review programme for biosimilars.

Boehringer Ingelheim joins other Big Pharma going into biosimilars

Biosimilars/News | Posted 30/09/2011

Big Pharma is once again taking a major interest in biosimilars. The latest big pharmaceutical player to show an interest is biopharmaceutical specialist Boehringer Ingelheim. The German-based company announced on 26 September 2011 that it would create a dedicated division for the development and commercialisation of biosimilars.

Amphastar’s biosimilar enoxaparin approved by FDA – Momenta launches lawsuit

Biosimilars/News | Posted 30/09/2011

On 19 September 2011, and after years of conflict with FDA, Amphastar Pharmaceuticals (Amphastar) finally received approval to market a biosimilar version of sanofi-aventis’s blockbuster blood-thinner Lovenox (enoxaparin). The announcement, however, was closely followed by news that Momenta Pharmaceuticals (Momenta) had launched a lawsuit against Amphastar.

Generics and biosimilars affected by Obama’s deficit plans

Biosimilars/News | Posted 23/09/2011

US President Barack Obama’s plan for economic growth and deficit reduction, announced on 19 September 2011, recommends a series of healthcare reforms. The proposals include higher drug rebates for low-income patients, banning pay-to-delay deals between generics and originator companies and reducing biologicals exclusivity from 12 to seven years. The proposals aim to save US$320 billion in healthcare spending over 10 years.

Sanofi announces new long-term objectives

Biosimilars/News | Posted 23/09/2011

At a ‘strategy and outlook’ seminar for investors held on 6 September 2011, sanofi-aventis (sanofi) CEO Mr Christopher A Viehbacher commented on the group’s outlook. The group has undergone radical changes since 2008, when it was faced with losing several blockbuster drugs over a relatively short time period, the so-called ‘patent cliff’. The main action sanofi took was to buy biotech company Genzyme and thus gain access to the biosimilars, rare diseases and multiple sclerosis markets. However, other actions not so interesting to the media have also played a great part in the company’s repositioning.

Hospira looks to biosimilars and increased use of generics for growth

Biosimilars/News | Posted 16/09/2011

Injectable generics leader, Hospira, announced on 7 September 2011 at its investor day, that it will look to biosimilars and international expansion for future growth.

FDA gives some insight into biosimilar pathway

Biosimilars/News | Posted 12/08/2011

FDA has outlined some of the requirements it intends to include in its biosimilars approval process in an article published in the New England Journal of Medicine [1]. The article is intended to give drugmakers, investors and other interested parties more insight into the approval process for biosimilars.

Partnerships will drive biosimilar development

Biosimilars/News | Posted 24/06/2011

With biosimilars tipped to become a multibillion-dollar market in the coming years, everybody is jumping on the biosimilars bandwagon, and it seems it’s not just limited to pharmaceutical companies.

Does industry support biosimilar user fees in the US?

Biosimilars/News | Posted 24/06/2011

According to FDA, biopharmaceutical trade groups are supportive of its proposal for biosimilar user fees, with sponsors paying an up-front fee with their applications.

Caution over IP provisions for biologicals in TPP

Biosimilars/News | Posted 17/06/2011

The US Generic Pharmaceutical Association (GPhA) has expressed its concerns over negotiations currently taking place on the Trans-Pacific Partnership (TPP) agreement.

Merck enters biosimilars deal with Korea’s Hanwha

Biosimilars/News | Posted 17/06/2011

US pharma giant Merck announced on 13 June 2011 an exclusive deal with South Korea’s Hanwha Chemical Corporation to develop and commercialise a biosimilar version of Amgen and Pfizer’s blockbuster rheumatoid arthritis drug Enbrel (etanercept).

Lupin and Neuclone biosimilars agreement

Biosimilars/News | Posted 10/06/2011

Indian generics manufacturer Lupin Pharmaceuticals has signed an agreement with Australian biotech firm NeuClone to access cell line technology to be used to develop biosimilar drugs targeting cancer.

Positive results for phase I trial of biosimilar erythropoietin

Biosimilars/News | Posted 09/09/2011

Hospira, self-proclaimed leader in injectable generics, announced on 6 September 2011 positive results from a phase I clinical trial of its biosimilar erythropoietin (EPO) carried out in the US in patients with anaemia associated with chronic renal (kidney) failure and chemotherapy.

Stada and Richter to collaborate on biosimilar development

Biosimilars/News | Posted 02/09/2011

German generics giant Stada Arzneimittel (Stada) and Hungary-based Gedeon Richter (Richter) announced on 30 August 2011 that the two companies have signed licence and collaboration agreements for the development and marketing of two biosimilars.

China’s 5-year biotech investment fires clear warning to US

Biosimilars/News | Posted 26/08/2011

The Chinese Government has targeted biotechnology as a ‘strategic pillar’ industry, and has pledged to spend 2 trillion yuan (Euros 213. 3 billion; US$308.5 billion) on science and technology in the next five years alone [1]. This has sent out a clear warning to the US Government that China aims to become the world’s pioneer in biotechnology in the short to medium term. In response, despite being under increasing pressure to reduce overall health expenditure, the US Government has resisted calls to cut funding and pledged US$ 32 billion to its National Institutes of Health biomedical research programme for 2012 [2].

Is FDA requesting too much data to allow biosimilars to succeed in the US

Biosimilars/News | Posted 26/08/2011

The FDA’s recently published plans for a biosimilar approval pathway are facing increasing scrutiny. In an interview with Scientific American, Novel Health Strategies’ biosimilar market entry advisor, Dr Saurabh Aggarwal, said that the level of data required by FDA is too much for biosimilars to be able to succeed [1].

EMA and FDA to collaborate on biosimilars

Biosimilars/News | Posted 01/07/2011

The EMA announced on 23 June 2011 that it had set up a new ‘cluster’ to collaborate with the FDA for the exchange of information on biosimilar drugs.

Mylan re-brands Matrix Labs to enter Indian market

Biosimilars/News | Posted 17/06/2011

US generics manufacturer Mylan announced on 27 May 2011 that it plans to rebrand its India-based subsidiary Matrix Laboratories as Mylan in order to launch its own prescription drugs in the emerging Indian market over the next year.

Interchangeability of biosimilars in the US

Biosimilars/News | Posted 27/05/2011

As drug manufacturers await guidance on a biosimilar approval pathway in the US, the debate goes on as to how high the bar will be set for the FDA to designate a biosimilar as interchangeable. In one critical area of the law that outlines biosimilar regulations, Congress outlines the difference between biosimilarity and interchangeability with respect to biosimilars and innovative biologicals, but the FDA has yet to define the difference.

Biosimilars user fees as high as brand-name fees

Biosimilars/News | Posted 13/05/2011

On 9 May 2011, the FDA proposed a user fee programme that would see drugmakers seeking approval to market biosimilars in the US initially paying fees similar to those required of originator biological drug developers.

Teva grabs biopharmaceutical company Cephalon

Biosimilars/News | Posted 06/05/2011

On 2 May 2011, Teva and Cephalon announced that they had unanimously approved a definitive agreement under which Teva will acquire all outstanding shares of Cephalon for US$81.50 per share in cash, or a total enterprise value of approximately US$6.8 billion.

Generics manufacturers and biosimilars

Biosimilars/News | Posted 29/04/2011

According to a report by the Wall Street Journal on 31 January 2011, generic manufacturers are expecting biosimilars to be the next cash cow, with sums in the multibillions of dollars expected to be reaped from this market in the near future.

Everybody jumping on the biosimilars bandwagon

Biosimilars/News | Posted 08/04/2011

According to a report by Reuters on 13 January 2011, Big Pharma is taking a major interest in the biosimilars market. During interviews with Amgen, Merck, and Biogen Idec at the JP Morgan’s 28th Annual Healthcare Conference in San Francisco, USA, biosimilars was the hot topic.

Boehringer Ingelheim acquires Amgen biotech site

Biosimilars/News | Posted 08/04/2011

Boehringer Ingelheim, one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals, announced on 25 March 2011 that it had formally acquired Amgen’s biopharmaceutical development and manufacturing facility in Fremont, California, USA.

Further lobbying over biosimilars

Biosimilars/News | Posted 01/04/2011

Brand-name drug companies are trying to weaken a provision of the US Patient Protection and Affordable Care Act that was designed to open up generic competition in biotechnology medicines and save billions of dollars. The industry, patients and providers are watching closely to see how the FDA will interpret the law, in documents that are expected to be released during late 2011.

Merck and Parexel form strategic alliance for biosimilars

Biosimilars/News | Posted 04/02/2011

Merck Sharp and Dohme (MSD – known in the US and Canada as Merck) and Parexel, a leading global biopharmaceutical services provider, announced on 12 January 2011 that they have entered into an alliance by which Parexel will provide a broad range of clinical development services for designated biosimilar candidates to Merck BioVentures. Merck BioVentures is a division of MSD that focuses on biosimilars.

Samsung to enter biosimilars market

Biosimilars/News | Posted 25/03/2011

Everybody is jumping on the biosimilars bandwagon these days, and it seems it is not just limited to pharmaceutical companies. Contract research organisation, Quintiles, announced on 28 February 2011 that it has entered into a deal with electronics giant Samsung to provide biologicals manufacturing and biosimilar development.

Spectrum to develop biosimilar monoclonal antibody

Biosimilars/News | Posted 04/03/2011

California-based Spectrum Laboratories announced on 5 January 2011 that it has signed an agreement with contract research organisation Viropro for the development of a biosimilar version of Roche’s blood-cancer drug Rituxan (rituximab).

Biosimilars boost for South Korea

Biosimilars/News | Posted 25/02/2011

The South Korean Government has pledged to promote the biosimilars industry and plans to invest in the biosimilars industry in order to make Korea a market leader. The government will provide both financial and institutional support and is aiming to take a 22% share of the global market by 2020.

Gedeon Richter sign biosimilars’ agreement with Mochida

Biosimilars/News | Posted 11/02/2011

On 14 December 2010 Budapest-based Gedeon Richter and Tokyo-based Mochida Pharmaceutical (Mochida) announced that the two companies have entered into a comprehensive and long term license and collaboration agreement with respect to development and marketing of Richter’s biosimilar product portfolio.

Sandoz announces biosimilar rituximab

Biosimilars/News | Posted 21/01/2011

Sandoz, the generic drug division of Swiss drug giant Novartis AG, announced on 10 January 2011 a phase II clinical trial for a biosimilar version of leading monoclonal antibody rituximab.

Contract manufacturing: top firms are investing

Biosimilars/News | Posted 10/12/2010

Lonza Group Ltd and ScinoPharm Taiwan Ltd, two leading manufacturers of active pharmaceutical ingredients (APIs), have struck separate deals to expand their capabilities to make biological drugs.

Pfizer and India-based Biocon make biosimilar insulin deal

Biosimilars/News | Posted 08/11/2010

Biocon, India’s largest biotechnology company by revenue and Pfizer—the world’s biggest pharma company—announced on 18 October 2010 that they have entered into a strategic global agreement for the worldwide commercialisation of Biocon's biosimilar versions of insulin and insulin analogs (recombinant human insulin, glargine, aspart and lispro).

FDA holds public hearing on biosimilars pathway

Biosimilars/News | Posted 29/10/2010

The FDA has taken further steps towards implementing guidelines on the approval pathway for biosimilars in the US by holding a public meeting on the matter.

Delays in FDA approval of biosimilar G-CSF (filgrastim)

Biosimilars/News | Posted 20/10/2010

Teva Pharmaceutical Industries announced on 30 September 2010 that the FDA has requested additional information for the Biologic License Application (BLA) for Neutroval (filgrastim), its biosimilar version of Amgen’s Neupogen (granulocyte colony-stimulating factor [G-CSF]). This action by the FDA will effectively delay any launch of the company’s first generic biotech drug in the US.

Australia approves first biosimilar filgrastim

Biosimilars/News | Posted 08/10/2010

On 26 September 2010 US-based generics manufacturer Hospira announced that it had received approval from the Therapeutic Goods Administration (Australia's regulatory agency for medical drugs and devices) for its biosimilar filgrastim product, Nivestim.

Cipla invests in biosimilars

Biosimilars/News | Posted 17/09/2010

India-based generics’ manufacturer Cipla is increasing its presence in the biosimilars’ market with major investments planned for the near future, according to a report in the Indian newspaper Business Standard.

Dr Reddy’s launches biosimilar Aranesp

Biosimilars/News | Posted 17/09/2010

Dr Reddy’s Laboratories increases its stake in the biosimilars’ market with the latest launch in India from its biosimilars’ programme. Cresp is the first generic darbepoetin alfa in the world, and the only darbepoetin alfa in India. Darbepoetin alfa is used for the treatment of anaemia due to chronic kidney disease and chemotherapy.

Good news for biosimilar enoxaparin sodium

Biosimilars/News | Posted 03/09/2010

French pharma giant sanofi-aventis (sanofi) has been denied a request to block sales of a generic version of its Lovenox blood thinner by a US district court.

FDA approves first biosimilar enoxaparin sodium

Biosimilars/News | Posted 13/08/2010

On 23 July 2010, Momenta Pharmaceuticals and Sandoz announced that they had received approval from the FDA for their biosimilar version of sanofi-aventis’s (sanofi-aventis’s ) blockbuster blood thinning drug, Lovenox (enoxaparin sodium).

Cipla enters the biosimilars market

Biosimilars/News | Posted 02/07/2010

India-based generics’ manufacturer Cipla is paying US$65 million to buy a significant minority stake in two Asian biotech companies with plans to develop a range of discounted biosimilars, generic substitutable versions of branded biologic drugs. Cipla's Chairman says he specifically wants to create follow-on therapies to three of Roche's top biologics – Avastin, Enbrel and Herceptin – that account annually for US$19 billion in sales.

Hospira’s biosimilar filgrastim product Nivestim approved

Biosimilars/News | Posted 25/06/2010

On 10 June 2010, Hospira received approval from the European Commission for its biosimilar filgrastim product, Nivestim, for the prevention of febrile neutropenia and reduction in duration of chemotherapy-induced neutropenia.

Development of a new biosimilar filgrastim product (Zarzio)

Biosimilars/News | Posted 04/06/2010

Filgrastim, a growth factor, is used to aid the recovery of bone marrow after chemotherapy treatment for cancer, especially in patients with neutropenia (low white blood cell count in the blood), causing reduced host defence.

Health Canada issues finalised guidance on biosimilars

Biosimilars/News | Posted 13/04/2010

Health Canada has released the finalised version of its Guidance Document on the approval of Subsequent Entry Biologics (SEBs), which is effective as of 5 March 2010.

Ranbaxy to develop biosimilars with US-based Pfenex

Biosimilars/News | Posted 06/04/2010

On 29 March 2010, Daiichi Sankyo’s Ranbaxy Laboratories in India announced its collaboration with US-based Pfenex on the development of an undisclosed biosimilar therapeutic protein with the Pfenex Expression Technology platform, a Pseudomonas-based recombinant protein expression technology.

US healthcare reform passed: Biosimilars Pathway in US with 12 years exclusivity for biologics

Biosimilars/News | Posted 02/04/2010

The US House of Representatives voted 219-212 on March 21 2010 to approve President Mr Barack Obama’s US$940 billion, 10-year health reform, and he could now sign the bill into law as early as 23 March 2010.