Drugs

Biosimilar Approvals Will Increase: FDAer

Speaking 4/17 at the National Policy and Advocacy Summit on Biologics and Biosimilars, CDER Office of New Drugs associate director Leah Christl said that over time the U.S. will see a dramatic increase in the number of biosimilar approvals, based on the quantity of applications that the agency is currently receiving. The Center for Biosimilars reports that Christl said that when FDA started on the biologics pathway eight years ago when the Biologics Price Competition and Innovation Act was implemented, it expected that biosimilar approval and uptake would proceed the way it had in Europe.

“We came in to having this approval pathway later than other areas of the world, and the expectation was that we would have companies bring to us the products that they had approved in other areas would just seek approval here,” Christl said. “But we didn’t see that. What we saw was the global development programs were ongoing, and they were bringing monoclonal antibodies.”

Currently, she said, the U.S. is seeing the same applications as Europe is seeing and there is a robust pipeline in regard to the applications being submitted for approval.

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