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Branded cardiovascular drugs not better than generics Generics/Research | Posted 29/07/2009

In December 2008, the Journal of the American Medical Association published an article on the clinical equivalence of generic and brand-name drugs used in cardiovascular disease by Aaron Kesselheim...

Views on biosimilars: Genentech Biosimilars/News | Posted 29/07/2009

Genentech has put a clear position on biosimilars on its website. The company explains that the terms ‘biosimilar’ or ‘follow-on biologic’ refer to products that are marketed after expiration of pa...

European biosimilars market set to grow gradually Reports | Posted 29/07/2009

A new report from Frost & Sullivan (F&S) has claimed that despite the initial regulatory hiccups, the number of biosimilars in the European market is set to increase gradually. It notes tha...

Blockbuster biologicals in 2008 possible targets for new biosimilars? Reports | Posted 29/07/2009

With the recently introduced two US biosimilar bills and the expectation that a US biosimilars pathway will be realised before the end of this year, the race for biosimilar (or biobetter) versions...

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...