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Health

Lawmakers propose “safety-first” approval pathway for biosimilars

March 12, 2009

U.S. Representatives Jay Inslee (D-Wash.), Anna Eshoo (D-California) and Joe Barton (R-Texas) today introduced legislation to establish a safe, science-based, and expedited approval pathway for biosimilar medications. Representatives Eshoo and Inslee were the lead sponsors of two separate biosimilar bills during the 110th Congress, and now have one bill with Rep. Barton to bring congressional stakeholders and interested parties to bipartisan consensus with this joint legislation.

Their bill, the “Pathway for Biosimilars Act,” will extend the therapeutic benefits of breakthrough biotech drugs to millions of Americans facing dire illnesses such as cancer and diabetes, while ensuring patient safety and protecting innovation in future R&D.

“With this legislation, we can create a pathway to lower-cost copies of biotech drugs without sacrificing safety or eliminating incentives to create breakthrough medicines,” said Inslee, who serves on the House Energy and Commerce Committee. “This is not an either-or situation. We can deliver both safety and broader access to these life-saving medicines, while ensuring continued biotech innovation. And we must.”

Inslee’s bill puts patient safety first by making sure that clinical testing of biosimilars, to the fullest extent deemed necessary by FDA scientists, is a core requirement of the bill’s approval pathway. “Ensuring patient safety needs to remain our highest priority. That’s why we’ve aligned our safety guidelines with the science-based consensus of the FDA, European regulators, and the American Medical Association. Even before introduction, the bill has received the support of eleven physician organizations and nine different patient groups,” said Inslee.

“Biotechnology can lead to cures for cancer, diabetes, and AIDS, and prevent the onset of deadly and debilitating diseases like Alzheimer’s, heart disease, and Parkinson’s,” added Rep. Eshoo. “But we need to preserve incentives to innovate and ensure that these therapies are safe and effective. Our bill accomplishes this. This bill sets forth a straightforward, scientifically based process for expedited approval of new biologics based on innovative products already on the market. This new biosimilars approval pathway will promote innovation, competition, and lower prices, but also ensures that patients are given safe and effective treatments that have been subjected to thorough scrutiny and testing by the FDA.”

"Congress needs to finally act on this issue,” said Barton, ranking member on the Energy and Commerce Committee. “Our bill promotes competition through biosimilars in a way that puts patient safety first and also encourages new therapies and medical advancement. I want the Energy and Commerce Committee to take up this issue soon, and I hope we can pass legislation this year."

Inslee, whose Seattle-area district is home to a robust biotech sector, also pointed to the job-saving strengths of this legislation. “The biotech revolution has been powered by American innovation, American research, and American technology. This bill will keep the pipeline of innovation flowing for the next generation of patients in need, and for the biotech industry workers who serve them. We’ve worked hard to achieve the right balance between promoting both price competition and reinvestment in innovative R&D for new therapies.”

The bill is supported by patient groups, including the ALS Association, American Autoimmune Related Diseases Association, Candlelighters Childhood Cancer Foundation, InterAmerican College of Physicians and Surgeons, Kidney Cancer Association, RetireSafe, Immune Deficiency Foundation, the Pain Foundation, and the Alliance for Aging Research.

Physicians’ groups have also lent their support to the bill, including the American Association of Neurological Surgeons, American Association of Orthopaedic Surgeons, American College of Emergency Physicians, American College of Obstetricians and Gynecologists, American Gastroenterological Association, American Society of Cataract and Refractive Surgery, American Urological Association, Coalition of State Rheumatology Organizations, Congress of Neurological Surgeons, Heart Rhythm Society, and the National Association of Spine Specialists.