Drugs

Biologic Product Marketplace Competition Comments

The American Medical Association (AMA) says it “strongly supports accelerating and expanding regulatory action to increase pharmaceutical market competition and combat anti-competitive practices.” Responding to an FDA public hearing on competition and innovation in the biological products marketplace, the association says it strongly supports FDA efforts to ensure a robust biosimilar market and is pleased to see biosimilar products finally becoming available for patients. “However,” it says, “to ensure uptake of biosimilar products by physicians and patients is successful, we support your efforts to ensure that there are no artificial barriers in place that may hinder integration of these products into treatment regimes. In general, the AMA is concerned with any regulatory actions that draw unnecessary distinctions between biosimilars and their reference products. With new products such as these, actions that seek to make strong distinctions between the reference product and the biosimilar that are not evidence-based and not clinically relevant may have the unintended consequence of giving that product an appearance of being less safe or less efficacious.”

In its comment, the Biosimilars Forum voices support for FDA’s goal of streamlining development of biosimilar and interchangeable products, enhancing the efficiency of FDA review, providing additional scientific and regulatory clarity to stakeholders, and facilitating development of novel and originator biologic drugs. It also responds to specific questions posed by FDA.

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