Drugs

Sandoz Enbrel Biosimilar ‘Highly Similar’ to Innovator: FDA

FDA reviewers are backing a Sandoz BLA (GP2015) for a biosimilar copy of Amgen’s Enbrel (etanercept) for treating arthritis. The agency’s Arthritis Drugs Advisory Committee is meeting 7/13 to review and vote on the submission.

“In considering the totality of the evidence submitted, the data submitted by the applicant show that GP2015 is highly similar to U.S.-licensed Enbrel, notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between GP2015 and US-licensed Enbrel in terms of the safety, purity, and potency of the product,” an FDA briefing document says. “The applicant has also provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use to support their request that GP2015 should receive licensure for each of the indications for which U.S.-licensed Enbrel is currently licensed and for which GP2015 is seeking licensure.”

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

Read more

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