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Biosimilars

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.