New draft industry guidance from the Food and Drug Administration (FDA) suggests the agency will change its approach to biosimilar review and no longer require comparative efficacy studies as part of an application for review.
The guidance states that if comparative analytical assessment (CAA) supports a demonstration the proposed biosimilar is highly similar to its reference product, “an appropriately designed human pharmacokinetic similarity study and an assessment of immunogenicity may be sufficient to evaluate whether there are clinically meaningful differences between the proposed biosimilar and the reference product in terms of safety, purity, and potency.”
The FDA has also stated its goal to make it easier for biosimilars to be developed as interchangeable with brand-name biologics.
ASGE is reviewing the guidance which will be open for public comment for 60 days after the draft guidance is published in the Federal Register. Publication has been delayed due to the federal government shutdown.