Drugs

Biologics Market Moving at ‘Appropriate Pace’: Attorney

Attorney David Fox (Hogan Lovells) told an AtlanticLIVE biosimilars policy briefing that while progress in the biosimilars market “may seem glacial, by lawyer and FDA standards this market is actually moving at the appropriate pace.” In an online post, Biosimilar Development says that the briefing demonstrated through its presentations that the adequacy of FDA’s review pace “depends on where you sit.”

In examining differences in approaches to biosimilar review between FDA and the European Medicines Agency, Apobiologix vice president Jim Van Lieshout said the U.S. is the only place attempting to regulate interchangeability, and demonstrating interchangeability is a contradiction to the abbreviated approval process because it’s “an add-on process.”

Fox said another difference between the two regulatory agencies is that FDA relies more heavily on its meeting process with individual applicants, while the EMA relies more on classwide guidances.

“The U.S. picked a resource-intensive approach in which they negotiate with individual sponsors on product-specific scientific issues,” Fox said. “I think … there were concerns that innovator companies would get too involved in the biosimilar programs, so FDA tried to shield that. But we might look back some day and think that this process consumes too many resources and isn’t efficient.”

While many members of Congress have stressed that they want to see fast biosimilar approvals, Fox recalled that it took 10 years for FDA to finalize the Waxman-Hatch regulations and some 15 more years for major court cases to be resolved. He says the fact that a biosimilar case is soon to be heard by the Supreme Court is a sign that the industry is where it needs to be at this time.

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