Biologics

FDA Abandoning Biosimilar Switching Studies

FDA is moving away from recommending switching studies to support an interchangeability determination for biosimilar products. In a just-published draft guidance, the agency is seeking comments on a revised approach where such studies will generally not be needed.

FDA’s recommendation for switching studies first appeared in its interchangeability guidance in 2019 (Considerations in Demonstrating Interchangeability With a Reference Product) before receiving and reviewing any applications for an interchangeable biosimilar. “Since publication of the interchangeability guidance, experience has shown that for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” an agency notice says.

In the past, FDA generally recommended switching studies as part of the data package needed to demonstrate a biosimilar’s interchangeability. However, it notes that “of the 13 approved interchangeable biosimilars, nine were approved without additional clinical (switching study) data.”

The agency says its scientific approach to when a switching study may be needed to support a demonstration of interchangeability has evolved. “FDA researchers found no differences in the risk of death, serious adverse events, and treatment discontinuations between participants who switched between biosimilars and reference products and participants who did not switch in a recently conducted systematic review and meta-analysis,” it says. “Additionally, today’s analytical tools can accurately evaluate the structure and effects biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies.”

Instead of conducting switching studies, the new draft guidance says biosimilar applicants can otherwise choose to “provide an assessment of why the comparative analytical and clinical data provided in the application or supplement support a showing that the switching standard set forth in section 351(k)(4)(B) of the PHS Act has been met. Any such assessment should include any other information the applicant considers relevant to support a showing that the risk, in terms of safety and diminished efficacy, from alternating or switching between the reference product and the proposed interchangeable product is not greater than the risk of using the reference product without such alternation or switch.”

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

Read more

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