Drugs

FDA Biosimilar Testing Now Faster Than EMA

Harvard Medical School researchers say that although the level of biosimilar testing needed for FDA approval exceeded the European Medicines Agency (EMA) level soon after the FDA biosimilar pathway was established, that is no longer the case. The researchers looked at 16 biosimilars of nine originator biologics that had been approved by both FDA and the EMA by 2/2019. They found that for 10 of the 12 biosimilars not approved for marketing in the European Union prior to 2015, the same clinical trials supported EMA and FDA approvals.

More recently, the authors report, FDA has approved some second-to-market biosimilar products without Phase 2 or 3 trials.

“The USA was late to establish a biosimilar pathway,” the article concludes, “but FDA has streamlined its approval process; it now approves many new biosimilars several months before the EMA. As more biosimilars are approved in the USA, policymakers must now grapple with other barriers to ensure that biosimilars reach the market, are priced at competitive levels, and are utilized by physicians and patients.”

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