Biosimilars/News

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.