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Clearing Another Hurdle on the Pathway to Biosimilars

July 31, 2009
The House Energy and Commerce Committee, by a vote of 47 to 11, overwhelmingly adopted an amendment creating a regulatory pathway for biosimilars that will provide 12 years of data exclusivity for innovative biologics. The strong bipartisan support for this amendment to the America’s Affordable Health Choices Act marks the second win this month for a fair and balanced approach to biosimilars market entry.

This vote was a clear victory for patients. The ALS Association and the Alliance for Aging Research were among a number of patient groups that registered their support for the amendment, introduced by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton (R-TX). The data exclusivity provisions included in this amendment will provide biotech companies with the protections they need to continue their search for new biomedical breakthroughs, providing increased hope to patients and their families that new therapies and cures will be discovered and made available to patients.

The amendment incorporated the principles of H.R. 1548, the Pathway for Biosimilars Act, which counts more than 140 House members as cosponsors, and an amendment approved by the Senate Health, Education, Labor and Pensions Committee on July 13th. The HELP Committee amendment, which was offered by Senators Orrin Hatch (R-UT), Mike Enzi (R-WY), and Kay Hagan (D-NC), passed by a bipartisan vote of 16 to 7.

Like the amendment sponsored by Eshoo, Inslee, and Barton, the amendment that passed the HELP Committee drew support from patient groups and other stakeholders such as the AIDS Institute, Minority AIDS Council, Children’s Tumor Foundation, National Kidney Foundation and the Vietnam Veterans of America.

Our thanks go to the many patient groups and other stakeholders, including the Association of American Universities and the National Venture Capital Association, who worked with us to educate Members of the House and Senate, and to Rep. Eshoo who worked tirelessly on this most important issue.

As I said previously, we are still a long way from finished, but we’ve won yet another battle.