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Policies & Legislation

BIO: Patent gap for biologicals ignored by Federal Trade Commission report

In the US, the outstanding issue surrounding the biosimilars debate remains the exclusivity period before competitors can come on the US market – and the US is no closer to a resolution following the 10 June 2009 report by the Federal Trade Commission (FTC), Emerging Health Care Issues: Follow-on Biologic Drug Competition.

Teva wants new rules for first generic entrants in EU

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 held in London, UK, in February. He said that once a product’s patent expired “everyone jumps on the bandwagon. What we need is an alternative way to continue the appetite to take risks in Europe.”

Regulatory approval of biosimilars in Europe

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 product is sufficient.