Biosimilars
Also noted on biosimilars: 11 May 2012
Sandoz testimony at FDA hearing on biosimilars will emphasise need for consistent regulatory standards across all biologicals
Sandoz announced on 9 May 2012 that Dr Mark McCamish, Head of Global Biopharmaceutical Development, would present on behalf of the Novartis Group of companies (Novartis) at the 11 May 2012 FDA public hearing on draft guidances for biosimilars.
The message he will convey will focus on the need for a single science-based regulatory standard that FDA should apply across all biologicals, irrespective of the business model of the sponsor. As well as a single standard, Dr McCamish will address the points that biosimilar clinical studies should be only confirmatory and the fact that interchangeability is critical to maximising access to affordable biosimilars for US patients.
Source: Sandoz
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.
Bioavailability comparison of brand-name and generic acetylcysteine in China
A study comparing brand-name and generic acetylcysteine in China by Liu et al has shown that the generics test formulation was bioequivalent to the originator drug [1].
EMA reviews its first biosimilar monoclonal antibody
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.
Study of biosimilar enoxaparins in Brazil
Analysis of biosimilar enoxaparins available for clinical use in Brazil by the Laboratório de Tecido Conjuntivo in Brazil have shown that the biosimilar preparations of enoxaprain are similar to the originator drug [1].
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.
