Managing Intellectual Property

Blow to biosimilars in amended US health care act

16 July 2009

Eileen McDermott, New York

A US Senate committee adopted an amendment to health care legislation on Monday night that will give 12 years of data exclusivity to innovative biologics

The amendment – adopted by the Senate Health, Education, Labor and Pensions (HELP) Committee and sponsored by Senators Orrin Hatch, Kay Hagan and Mike Enzi - represents an important win for the biotechnology industry.

The Obama administration, the Federal Trade Commission (FTC) and groups including the America Association of Retired Persons (AARP) all have proposed much shorter periods of protection before allowing biosimilar products on the market.

A biosimilar, or follow-on biologic, is a product that attempts to replicate a biologic – a...



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