Drugs

GPhA, Biosimilars Council Oppose ‘Biosimilarity Statement’

Joint comments from the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council have raised concern about a proposed biosimilarity statement recommended in a draft guidance on Labeling for Biosimilar Products because they say it is not only unnecessary but also may be confusing to patients and healthcare providers. The recommendations for biosimilar labeling in the document pertain only to the package insert, except for recommendations that pertain to FDA-approved patient labeling such as patient information, Medication Guides, and instructions for use. They include general principles for draft labeling of proposed biosimilar products, specific recommendations on content of biosimilar product labeling, FDA-approved patient labeling, revising biosimilar product labeling, instructions for submitting initial and revised labeling, and a discussion about interchangeable biological products.

The groups say FDA’s draft does not provide any information that physicians or patients need in order to use the product in a safe and effective manner. “This becomes obvious upon reviewing FDA’s labeling regulations, which do not identify any appropriate section of the labeling in which to place a biosimilarity statement,” they say. “Although FDA attempts to ‘shoe horn’ this information into the ‘Highlights’ section of labeling, it certainly does not merit placement there because it unquestionably is not one of the most important pieces of information about a biosimilar product. Nor does it not fit anywhere else in the labeling of a biosimilar product.”

Additionally, the comments say the biosimilarity statement may suggest to patients and healthcare professionals that biosimilars have clinically meaningful differences from their reference products regarding safety, purity, or potency when, in fact, they do not. “This, in turn, could impede the uptake and use of biosimilar products and impair effective competition,” they say, while urging FDA to reconsider requiring a biosimilarity statement on biosimilar labeling.

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