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FDA, in its draft guidance for biosimilars, has said that biosimilars can use different drug delivery devices than the corresponding reference product.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

Samsung to launch biosimilars by 2015 at half the current prices

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

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

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

Fujifilm and Kyowa launch biosimilars joint venture

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

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.

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