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BUGS IN BIOTECH BILLS

Exclusivity won't stop competition

November 30, 2009

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THE BIOSIMILARS provisions included in the health care reform bills currently before the US House and Senate meet the broad goals of reform: They would lower costs, expand access, ensure patient safety, and encourage continued innovation.

Your editorial misleadingly compared the 12 years of data exclusivity in the biosimilars legislation with the five-year provision for traditional pharmaceuticals. This apples-to-oranges comparison overlooks the fact that biologics cannot achieve the same kind of patent protection as pharmaceuticals.

Data exclusivity does not prevent competition. Companies can bring competitive products to market during the exclusivity period, provided they conduct their own safety and efficacy research. They cannot piggyback on an innovator’s proprietary data to obtain FDA approval until the exclusivity period ends. That’s simply fair.

The current bipartisan-backed provisions set a safe and reasonable pathway for approval of biosimilars. Moreover, they will help stimulate the growth of Massachusetts’ biotech sector, creating high-wage jobs in our burgeoning innovation economy.

ROBERT K. COUGHLIN
Cambridge
The writer is president of the Massachusetts Biotechnology Council.

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