Biosimilars slated for 12 years market exclusivity

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In a move applauded by brand name manufacturers, the Senate Health, Education, Labor and Pensions Committee and its House counterpart voted in July to support 12 years market exclusivity for biologic innovators under a follow-on biologics (biosimilars) provision attached to its healthcare reform bill.

It now awaits passage in each chamber, reconciliation in a conference and final votes after the August recess.
“The language approved … strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical breakthroughs,” said Biotechnology Industry Organization president Jim Greenwood.

Both committers had “embraced our long-held belief that a minimum of 12 years of data exclusivity establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of competition,” he said. 

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