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Biosimilar monoclonal antibody approved in Korea

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

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

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

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

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

FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.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

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

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

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

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.

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