FDA Streamlines Biosimilar Approval Process, Aiming to Lowerโค Drug Costs
The Food andโ Drug Administration (FDA) announced new guidance Wednesday designed to accelerate the approval of biosimilar drugs – copycat versions of complex biologic medications โค- โคand increase patient access to potentially lower-cost treatments. The changes aim to addressโ longstanding barriers that have hinderedโฃ the uptake of biosimilars in the U.S.
Currently, โdevelopers of biosimilars, used for conditions like arthritis and other autoimmune disorders, are required to conduct extensive clinical trials โto demonstrate equivalence to โขthe โoriginal brand-name drug. Under the new guidance, โคthese lengthy and expensive trials will no longer โขbe mandatory.Rather, โdevelopers will need โto demonstrate similarity in the drug’s structure โคand manufacturing โฃprocess.
The FDA also intends to simplify the process for pharmacistsโฃ to substitute biosimilars for brand-name drugs, mirroring the existing practice with generic โmedications.
“Forโ too long,government bureaucracy โand regulatory barriersโ have protected monopolies and stifled competition,”โ U.S. Health Secretary Robert โขF. Kennedy Jr. stated duringโ a news conference.
FDA Commissioner Dr. Marty Macary estimates the changes โคcould halve the approval timeline, reducingโ it from five โto eight years,โฃ and save companies tens โคof millions of dollars in researchโฃ costs, ultimately leading to lower prices for patients.
While industry experts acknowledgeโฃ the potential benefits, some caution that the regulatory changesโ may not fully resolve the issue. โBrian Skorney, a drug industry analyst at Baird, noted thatโค patent protections and legal challengesโข 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 โapproximately 90% of prescriptions filled in the U.S., they represent only โคa small portion of total drug expenditures. Biologic drugs, the targetโข ofโ biosimilar โฃreplacements, โcontinue to be a significantโค contributor to rising drug costs.
PHRMA, the lobbying group representing brand-name drugmakers, counteredโ that pharmacy benefit managersโข – 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 โhas been slow. The โขFDA hopes this initiative will expediteโฃ the processโ and broaden access for both patients and drugmakers.
More information โon โขbiosimilar medicines is available from the american Cancer Society: โ https://www.cancer.org/cancer/managing-cancer/treatment-types/biosimilar-drugs.html.
