FDA Streamlines Biosimilar Approval Process, Aiming to Lower Drug Costs
The Food and Drug Administration (FDA) announced new guidance Wednesday designed to accelerate the approval of biosimilar drugs – copycat versions of complex biologic medications - and increase patient access to potentially lower-cost treatments. The changes aim to address longstanding barriers that have hindered the uptake of biosimilars in the U.S.
Currently, developers of biosimilars, used for conditions like arthritis and other autoimmune disorders, are required to conduct extensive clinical trials to demonstrate equivalence to the original brand-name drug. Under the new guidance, these lengthy and expensive trials will no longer be mandatory.Rather, developers will need to demonstrate similarity in the drug’s structure and manufacturing process.
The FDA also intends to simplify the process for pharmacists to substitute biosimilars for brand-name drugs, mirroring the existing practice with generic medications.
“For too long,government bureaucracy and regulatory barriers have protected monopolies and stifled competition,” U.S. Health Secretary Robert F. Kennedy Jr. stated during a news conference.
FDA Commissioner Dr. Marty Macary estimates the changes could halve the approval timeline, reducing it from five to eight years, and save companies tens of millions of dollars in research costs, ultimately leading to lower prices for patients.
While industry experts acknowledge the potential benefits, some caution that the regulatory changes may not fully resolve the issue. Brian Skorney, a drug industry analyst at Baird, noted that patent protections and legal challenges from brand-name drugmakers frequently enough delay biosimilar launches even after FDA approval. “I don’t really see this regulatory change as an alleviation of the real bottleneck,” he said.
Despite generic and biosimilar drugs accounting for approximately 90% of prescriptions filled in the U.S., they represent only a small portion of total drug expenditures. Biologic drugs, the target of biosimilar replacements, continue to be a significant contributor to rising drug costs.
PHRMA, the lobbying group representing brand-name drugmakers, countered that pharmacy benefit managers – the intermediaries negotiating drug prices – also contribute to limited biosimilar access. Kennedy echoed concerns about industry influence,accusing pharmaceutical companies of lobbying to maintain their profits.
As the first biosimilar was approved in 2015, over 60 have entered the U.S. market, but adoption has been slow. The FDA hopes this initiative will expedite the process and broaden access for both patients and drugmakers.
More information on biosimilar medicines is available from the american Cancer Society: https://www.cancer.org/cancer/managing-cancer/treatment-types/biosimilar-drugs.html.
