Biologics

Inspection of Alvotech’s Biosimilar Ends in Rejection

FDA has issued Alvotech a complete response letter on its BLA for AVT05, a biosimilar to Janssen Pharmaceuticals’ Simponi (golimumab), in both prefilled syringe and autoinjector formats. The letter cited deficiencies identified during a July pre-license inspection of Alvotech’s Reykjavik manufacturing facility, according to the company. Alvotech says the issues must be resolved before the BLA can be approved, and the agency did not flag any other concerns with the application. The Reykjavik facility remains FDA-approved for production of currently commercialized products, it adds.

Simponi is approved for treating inflammatory conditions like rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Common side effects include infection, and serious risks include an increased risk of infections like tuberculosis, and other serious conditions like cancer or heart failure. The company says no biosimilars for Simponi have yet been approved in the U.S.

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