Drugs

More Support for Treating All Biologics the Same

The Association for Accessible Medicines and its Biosimilars Council say they support FDA’s approach to applying the same principles to postapproval manufacturing changes for all 351(k) biological products, regardless of whether they are licensed as biosimilar or interchangeable. “Importantly, and consistent with FDA regulations and guidance, these same principles, namely evaluating comparability of the prechange and postchange product, apply to all biological products irrespective of the licensure pathway,” the comment letter says.

The organizations say they are concerned that an FDA draft guidance with questions and answers on postapproval manufacturing changes to biosimilar and interchangeable biosimilar products suggests that a separate demonstration of adequate assurance that a postchange product remains biosimilar to or interchangeable with the reference product may be needed, even when the applicant submits sufficient data to enable an informed prediction that no adverse impact on the quality, safety, or efficacy of the postchange product is expected. “This introduces unpredictability to the process and could lead to unnecessary work and delays in implementing important manufacturing changes to the detriment of patients,” they say.

The associations recommend specific changes to the guidance text.

In its response, Pharmaceutical Research and Manufacturers of America recommends a clarifying revision to the discussion of product quality data in the draft guidance, in addition to supporting the FDA approach to using historical analytical data in analytical comparability data.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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