greenwood picBiotechnology Industry Organization (BIO) President and CEO Jim Greenwood held a press conference today on the issues facing the biotech industry this fall, namely, the healthcare reform going on and the energy/climate issues.  Greenwood reiterated that the organization’s goal is to relieve suffering across the globe.

BIO emphasized that it worked very hard to make sure that any amendment to create a regulatory pathway for biosimilars by the House Energy and Commerce Committee would contain 14 years of data exclusivity.  See America’s Affordable Health Choices Act (H.R. 3200).  Earlier, the House of Representatives’ Energy and Commerce Committee voted 47-11 in favor of allowing 12 years of data exclusivity for biotech drugs.

In creating a pathway for approval of biosimilars, BIO wants to preserve sufficient incentives for innovator companies and venture capitalists to commit the substantial investments necessary to develop such discoveries into new biologic treatments, as well as to provide a pathway for entry of biosimilars into the market to promote broad, affordable public access to such treatments.

BIO wants to have any final rules include the provisions of the amendments by Rep. Anna Eshoo, which includes key features of H.R. 1548, endorsed by AAU, and the Hatch/Enzi/Hagan Amendment recently adopted by the Senate Health, Education, Labor and Pensions Committee.  These provisions are supported by a wide range of groups including BioOhio and KentuckyBioAlliance (see EIB Supporters Ad).

See also:

  • Letter from 160+ stakeholders to the late Chairman Kennedy and Ranking Member Enzi in support of a pathway for biosimilars (pdf)
  • Letter cosigned by four HIV/AIDS advocacy organizations to the late Chairman Kennedy in support of a pathway for biosimilars (pdf)
  • BIO press release on House Energy & Commerce bipartisan approval of biosimilars amendment to health care reform legislation (pdf)
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