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’.