Biologics

AbbVie Petitions FDA on Biosimilar Interchangeability

AbbVie has petitioned FDA asking that it ensure that any biosimilar interchangeability determinations meet the “safety standards for determining interchangeability” set forth in Public Health Service Act section 351(k)(4) with respect to each condition of use for which the reference product is licensed, regardless of whether the applicant intends to label its product for every one of those uses. AbbVie further requests that the agency clarify that the statutory standards for establishing interchangeability differ in both kind and scope from the standard for establishing biosimilarity.

Additionally, the petition asks that FDA convene a hearing to obtain public input on the topic. “Interchangeability raises complex questions that are fundamentally different from those presented by biosimilarity,” it says. “A public hearing on interchangeability, including the implications of interchangeability determinations in a multi-source product environment where multiple biological products may have been found interchangeable with a single reference product, but not each other, will help to protect patients by ensuring that all viewpoints are heard. The agency should then issue guidance or regulations that address this important public health issue.”

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