Category Archives: Jim’s Corner

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 Read More >

Biomedical innovation is not only key to our industry’s future, but more importantly, continued medical breakthroughs are vital to patients living with debilitating diseases and their families. Without ongoing progress in our industry, patients of today and tomorrow have limited hope for future cures and therapies. Many patient groups have entered the debate on Capitol Hill over establishing a pathway for approval of biosimilars because they know how critical continued innovation is to finding new Read More >

Last evening the Senate Health, Education, Labor and Pensions (HELP) Committee adopted an amendment to the healthcare reform package that provided 12 years of data exclusivity for innovative biologics. This event was a significant victory for our companies and for patients. Two and a half years ago Senator Clinton and Congressman Waxman introduced bills that provided zero years of data exclusivity. Following extensive negotiations, Senators Kennedy, Enzi, Hatch, Schumer and Clinton agreed to a bill Read More >