Biologics

FDA Letter Articulates Biosimilar Naming Convention

FDA has posted a response to three citizen petitions that offered recommendations on biosimilar nonproprietary naming policies culminating in its final guidance on Nonproprietary Naming of Biological Products, which requires biological products to have a nonproprietary name that includes an FDA-designated four-letter suffix. The document says that under this convention, the “nonproprietary name for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.” The guidance applies both prospectively and retrospectively.

Petitions from the Generic Pharmaceutical Association and Novartis maintained that assigning unique nonproprietary names to biosimilar products would compromise patient safety. In its response letter, FDA disagreed, arguing that requiring a distinguishing suffix will help health care providers and others accurately identify and differentiate among products. “This should increase the likelihood that the intended biological product will be prescribed and that a different product will not be inadvertently substituted for the prescribed product at the dispensing level,” the letter says. A separate petition from Johnson & Johnson supported the naming convention that FDA chose.

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