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Biosimilars

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) that will soon enter the market, and that the impact on safety and efficacy is critical for patient safety. “Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions”, states Professor Huub Schellekens in Biosimilar therapeutics – what do we need to consider in NDT Plus. 2009;2(Suppl 1):i27-i36.

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 Henry Waxman, Chairman of the House Energy and Commerce Committee. Both bills would create the first US approval pathway for follow-on biologics. The bills differ in areas such as length of exclusivity for innovators and the need for guidance documents.

Waxman: US biosimilars market opens this year

Biosimilars/News | Posted 06/07/2009

“Seeing a pathway for biological generics is one of my highest priorities this year,” US Congressman Henry Waxman said via a video link to the World Generics Medicines Congress Europe 2009, held in London, UK, in February.