Drugs

Consider Alternate Interchangeability Methods: Study

Researchers from Pfizer and several universities say that sponsors should consider alternative approaches to statistical analysis that could meet FDA expectations for demonstrating the interchangeability of biosimilars. Writing in the open-access journal BioDrugs, the researchers say it is challenging to conduct clinical studies to support an FDA designation of interchangeability as defined in an agency guidance.

“Clinical studies that support interchangeability should be designed primarily to evaluate if clinical performance is altered by multiple switching between a reference product and its biosimilar and whether such switching will result in differences in pharmacokinetics or immunogenicity profiles,” the paper says.

The authors say the legal requirement to demonstrate interchangeability exists even though from a clinical perspective the risk associated with switching between a biologic reference product and its biosimilar is improbable. “The potential for changes in immunogenicity, such as heightened or altered immunogenic response, as a consequence of switching between a reference product and its biosimilar is not supported by evidence,” the authors say.

They note that using pharmacokinetic parameters as primary endpoints for clinical interchangeability studies to support an interchangeability designation of biosimilars creates new challenges.

“Interchangeability should be assessed on a case-by-case basis, considering the totality of the evidence and biologic plausibility,” the article concludes. “Alternative approaches to statistical analysis (e.g., use of asymmetric rather than symmetric margins to test equivalence) and study designs that meet FDA’s expectations for demonstration of interchangeability should be considered.”

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