Drugs

Streamline and Update Biosimilar Development: Council

The Biosimilars Council, a division of the Association for Accessible Medicines, says the biosimilar development paradigm in the U.S. should be updated and streamlined to reflect new scientific understandings. In a position paper, the council says an updated development paradigm “must account for scientific advances that allow for the elimination of unnecessary regulatory requirements, such as clinical efficacy studies, when data from analytic and pharmacokinetic studies have already demonstrated there are no clinically meaningful differences between the biosimilar and its reference product.”

The council says analytic methods are now sensitive enough to detect small differences between a biosimilar and a reference product, differences that previously might have created sufficient residual uncertainty for FDA to request comparative studies.

The council makes these recommendations for FDA:

eliminate unnecessary clinical efficacy studies; and
establish global regulatory comparators to support a demonstration of biosimilarity.

“Streamlining the biosimilar program using robust scientific tools and advanced analytical methodology will help to make high-quality biosimilars available for patients more quickly and at a lower cost, without any difference in safety or effectiveness,” the council concludes.

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