Drugs

Support for FDA Biosimilar Comparative Studies Draft Guidance

Four stakeholder organizations are voicing basic support for an FDA draft guidance, Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies. Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports a “totality of the evidence” approach to determining whether comparative efficacy studies (CES) are necessary for specific therapeutic proteins. “However,” the association writes, “since FDA’s experience in approving biosimilars is limited to certain monoclonal antibodies and other currently approved proteins, we urge FDA to retain a science-based approach that evaluates the totality of the circumstances, particularly for more complex and novel products. We also recommend that FDA provide more detail on the precise scientific factors that FDA will assess when considering whether a CME is not necessary, with examples.”

PhRMA makes the point that the agency has ample statutory authority to determine that a CES is unnecessary, but there remain circumstances where such studies might be needed.

In its comment letter, the Biosimilars Forum says:

it supports and agrees with FDA’s updated recommendations concerning CES;
FDA’s recommendation that biosimilar manufacturers approach the agency to discuss study plans in the CES draft guidance is important and must be appropriately supported by the agency;
FDA should expeditiously finalize its recommendations that clinical switching studies are generally unnecessary for interchangeability; and
FDA should discontinue routinely requiring direct pharmacokinetic comparisons against a U.S.-sourced reference product.

The Biosimilars Council says it agrees that comparative efficiency studies are generally unnecessary.

Finally, the United States Pharmacopeia says it supports the agency’s proposal to reduce reliance on CES when robust analytical comparability and pharmacokinetic studies are sufficient to establish biosimilarity. Its general comments cover a role for public standards and harmonization.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome