Biosimilars/News

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.