FDA to Deliver Guidance on Interchangeability, Analytics for Biosimilars
The FDA intends to clarify its expectations for demonstrating the interchangeability of biosimilars with reference products, an FDA official said.
The agency plans to issue recommendations on statistical techniques for evaluating analytical similarity data as well, said Steven Kozlowski, director of CDER’s Office of Biotechnology Products, at the 2016 GPhA Biosimilars Council Conference on Thursday.
These are just two of the tasks the FDA will undertake to address the murkier aspects of biosimilar development. Kozlowski noted that the agency also aims to host webinars and presentations at professional societies.
In his remarks, Kozlowski outlined the FDA’s stance on several requirements for biosimilars. For instance, he reminded drugmakers that the FDA takes into consideration the totality of evidence when approving a biosimilar.
And although industry has expressed concerns about the FDA’s guidance on biosimilar labels, Kozlowski reiterated that the FDA recommends that a biosimilarity statement appear on product labels for added transparency.
The FDA has received requests for meetings on the development of biosimilars for 20 reference products, he said.
Biosimilars See Rise in Adoption, Development
In the EU, biosimilars are poised to join the main market as prescribers widely embrace the lower-cost, copycat versions of brand-name drugs.
With each new approval, the adoption of biosimilars becomes more widespread across Europe, Aaron Gal, a senior analyst for Sanford Bernstein, said.
On the market, the newest biosimilars outperform earlier approved copycat versions, he explained. This trend coincides with a growing comfort among prescribers to dispense these drugs to patients.
In less than a decade, apprehension toward prescribing biosimilars has dwindled due to the lack of adverse events linked to biosimilar use, Gal said.
The U.S. market is seeing a comparable uptick in biosimilar prescriptions, but lags behind the EU in approvals. The FDA has approved three biosimilars, while the EU boasts 21 approvals.
Several surveys, however, indicate that physicians generally feel comfortable with substituting biosimilars for brand-name drugs, Gal said, which clears one hurdle for biosimilars on the market.
In the EU and U.S., biosimilar pipelines continue to flourish. Drugmakers reported having 22 biosimilars in their portfolios in early 2013, but about three years later, that number had risen to 70.
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