Drugs

FDA Trims, Updates Biosimilars Labeling

FDA is seeking public comment on the usefulness of biosimilarity statements in the product labeling. In an online post, CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim says FDA is recommending that all labeling for biosimilars, including interchangeable biosimilars, include a biosimilarity statement, rather than both a biosimilarity statement and an interchangeability statement.

Yim writes that while the prescribing information is written for healthcare professionals, information about interchangeability is relevant for substitution at the pharmacy. “We believe that statements in the prescribing information identifying that products have been approved as interchangeable with the reference product and describing the interchangeability standard are not necessary for informing the safe and effective use of the product to prescribing healthcare professionals,” she says…. “Moreover, as we gain more experience with licensing biosimilar and interchangeable biosimilar products, we are finding that a single biosimilar application and associated prescribing information may include both biosimilar and interchangeable biosimilar products at the same time.”

Yim also notes there may be inaccurate perceptions that interchangeable biosimilars are safer or more effective than biosimilars that are not approved as interchangeable. “The interchangeability designation does not indicate a higher level of biosimilarity,” she explains. “Healthcare professionals can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products. Including biosimilarity statements in the prescribing information for both biosimilar and interchangeable biosimilar products may avoid confusion among healthcare professionals about the significance of FDA’s determination that a biosimilar is interchangeable with the reference product.”

The post also discusses general biosimilar labeling recommendations and the impact on prescribers and pharmacists.

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