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US biosimilars bill with competition after just five years Biosimilars/News | Posted 29/07/2009

On 11 March 2009, Henry Waxman, Frank Pallone, Nathan Deal, and Jo Ann Emerson, all members of the US House Committee on Energy and Commerce, introduced the Promoting Innovation and Access to Life-...

Regulatory approval of biosimilars in Europe Policies & Legislation | Posted 06/07/2009

Biosimilars present a new set of challenges for regulatory authorities compared with conventional small-molecule generics, for which the demonstration of pharmacokinetic similarity to the reference...

Teva wants new rules for first generic entrants in EU Policies & Legislation | Posted 06/07/2009

In Europe first EU generic entrants should be given a period of market exclusivity, Teva Europe President and CEO, Dr Gerard Van Odijk, claimed at the World Generic Medicines Congress Europe 2009 h...

Key issues with biosimilars: impact on patient safety Biosimilars/Research | Posted 06/07/2009

The primary safety concern for biosimilar agents is their potential immunogenicity. Using biopharmaceuticals to replace endogenous proteins that may be present at insufficient concentrations carrie...

What physicians need to know about biosimilars Biosimilars/Research | Posted 06/07/2009

Physicians should become aware of potential differences between biopharmaceuticals (biologicals) and their generic versions (called biosimilars in the EU and follow-on protein products in the US) t...

Pressures on generic medicines put EU healthcare at risk Generics/General | Posted 06/07/2009

“The future of the European generic medicines industry is under serious threat, which places both the sustainability of European health care and the European industrial competitiveness at serious r...

Nomura: Generics growth will be steady for EU but anaemic for US Generics/News | Posted 06/07/2009

Between now and 2012, growth in the European generics market is expected to expand at less than 10% a year according to Ms Frances Cloud, co-head of healthcare investment banking at Nomura Internat...

Second US biosimilars bill introduced: 12 instead of five years market exclusivity Biosimilars/News | Posted 06/07/2009

On 17 March 2009, US Congresswoman Anna Eshoo (Democrat of California, USA) introduced a second biosimilars bill in the House that will compete with the bill introduced a week ago by US Congressman...