Drugs

3 Stakeholders Nix Biosimilar PSGs

Comments from three biosimilar industry stakeholders are rejecting the idea of FDA developing product-specific guidances (PSGs) for biosimilars. In its response, Sandoz says that PSGs are ill-suited to biosimilars. “Biosimilar development is a complex process that does not follow a rigid one-size-fits-all model and the current pace of scientific advancement demands a nimble and nuanced approach by FDA in its review and approval of biosimilars,” the company says.

Sandoz urges the agency to give careful consideration to the role of comparative clinical efficacy studies in biosimilar development, arguing that they are “minimally informative.” It says that investing FDA time and resources into reevaluating the utility of comparative clinical efficacy studies, as opposed to diverting the agency’s attention to PSGs, will help support biosimilar development and address the biosimilar void.

The Biosimilars Forum says it does not support the development of either product-specific guidance or product class-specific guidance, saying they would slow the development of biosimilars and would be an inappropriate use of BsUFA funds.

The letter sent by the Biosimilars Council says, “We believe that work on foundational non-product specific guidances would be a much better expenditure of resources to advance biosimilar development and improve patient access to affordable biosimilar medicines. Furthermore, FDA has other tools that it can use to inform biosimilar development that are preferable to biosimilar PSGs. We expect FDA to notify the industry if it decides to develop biosimilar PSGs and that any such decision would ne accompanied by FDA’s rationale and an estimate of the FTE (full-time equivalent) resources necessary for PSG development and maintenance. This is particularly important as resources for the biosimilars program are limited and FDA has made commitments as part of the reauthorization of the Biosimilar User Fee Act that must remain a higher priority.”

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