Drugs

Treat all Biologics the Same: Stakeholders

Responding to an FDA draft guidance on questions and answers about post-approval manufacturing changes to biosimilar and interchangeable biosimilar products, Samsung Bopepis questions the need for an additional guidance since all biologics should be treated the same. “Regulatory consistency and the application of the same regulatory science by regulators at FDA, and ideally elsewhere, across all biologics is crucial,” the comment letter says. “Regulators should not be considering the business model of sponsors and once approved a biosimilar is first and foremost always a biologic. This is the only way to be fair and the only way to enhance all stakeholder confidence in all biologics, including biosimilars.”

Samsung says it is concerned about having a separate guidance unique to the U.S. for post-approval manufacturing changes to biosimilar and interchangeable biosimilar products. “It is not needed,” it says, “and worse, it could be used to imply that there are additional or merely different risks for 351(k) products compared to other biologics already licensed under 351(a). Fundamentally, biosimilar and interchangeable biosimilar products are already biologics, just like their reference products, and all issues pertaining to quality, safety, and efficacy (safety, purity, and potency) of biologics already must and do apply. There are very real risks created by two separate guidances that attempt to address the same regulatory issues as they could be amended differently over time and get out of sync.”

In its response, the Biosimilars Forum says that overall it supports the guidance and the process outlined in it. The letter says it would be important for FDA to state that the principles in the guidance apply to all biologics, regardless of the approval pathway. The Biosimilars Forum also makes specific recommendations for changes to the guidance.

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