Drugs

FDA Drops Interchangeability Switching Studies

In a 6/20 update to a 2019 guidance, FDA revised the need for switching studies to demonstrate a biosimilar is interchangeable. In an online post, attorney Robert Schwartz (Venable) says the update is based on the agency’s experience gained in approving 13 interchangeable biosimilars since the 2019 guidance and current scientific thinking and analytical assessment techniques.

“Experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” FDA says in the updated guidance. Schwartz says that finding “has caused an evolution in FDA’s thinking about the need for switching studies to demonstrate interchangeability.”

Under the revision, the agency says, applicants may “choose to provide an assessment of why the comparative analytical and clinical data provided in the application or supplement support a showing that the switching standard … has been met.” It says any such assessment should include any other information the applicant considers relevant to support a showing that the risk, in terms of safety and diminished efficacy, from alternating or switching between the reference product and the proposed interchangeable product, is not greater than the risk of using the reference product without such alternation or switch.

Schwartz says FDA noted that nine of the 13 interchangeable biosimilars approved as of the date of the new guidance were approved without switching studies. “Despite switching studies previously being viewed as a requirement, and significant hurdle to obtaining an interchangeability designation,” he writes, “it appears that has not been the case, and the updated guidance’s revised approach follows consistent FDA flexibility regarding interchangeables.”

FDA is receiving comments on the updated guidance until 8/20.

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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