With Congress focused intently on the discovery, development, and delivery pipeline for innovative drugs and devices – and in the wake of the first-ever U.S. approval of a biosimilar medication– key policy and regulatory questions are being actively debated, with important implications for industry, patients, and the health care system.
This briefing provided essential background on the U.S. and international markets for reference biologics and biosimilars, outline current policy and regulatory issues, and describe implications for the future, answering questions such as: How are reference biologics and biosimilars regulated, and what are key differences between regulatory frameworks for biosimilars and generic drugs? What can the U.S. learn from the international market for biosimilars? What is the key to balancing innovation and affordability? How do health care providers and patients view the biosimilars market? What does the future hold for the reference biologic and biosimilars markets?
If you were unable to attend the briefing, here are some key takeaways:
- Amanda Bartelme, director, Avalere
Biosimilars are analogous to generic drugs, but producing biosimilars is much more dependent on the manufacturing process, said Amanda Bartelme of Avalere. The Biologics Price Competition and Innovation Act (BPCIA), part of the Affordable Care Act (ACA), created a new pathway for biosimilar approval and the classifications of biosimilar as well as interchangeable drugs, and CMS has released guidance for Medicare Part B, Medicare Part D and Medicaid in reference to biosimilars.
- Sally Howard, J.D., deputy commissioner for policy, planning, and legislation, Food and Drug Administration
The Food and Drug Administration (FDA) plans to issue guidance on the naming of biosimilars later in 2015, noted Sally Howard, J.D., deputy commissioner for policy, planning, and legislation, FDA. When coming up with a naming system, the FDA must consider ease of use, safety, pharmacovigilance, and whether or not a biosimilar manufacturer will be disadvantaged, she added.
- Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira
The introduction of biosimilars into the American market will drive innovation and affordability, thereby increasing access and improving outcomes, stated Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira. Creating an environment that fosters sustainability for biosimilars in the market is key, he added.
- Geoff Eich, executive director, external affairs for Amgen Biosimilars
Four key steps for ensuring patient and physician confidence in biosimilars are proper regulatory standards, transparent disclosure of data for side-by-side comparisons, single-point accountability of manufacturers for the quality of their individual product, and education for healthcare professionals about changes in the pharmaceutical market and regulations, stated Geoff Eich, executive director, external affairs for Amgen Biosimilars. He emphasized the need for a high quality, patient-focused biosimilar program.
Ed Howard of the Alliance for Health Reform moderated the panel discussion.
Contact: Sarah Dash, firstname.lastname@example.org, 202-789-2300
Follow the briefing on Twitter: #biosimilars
Full Transcript (Adobe Acrobat PDF)