Drugs

Inspection Form 483 for Alvotech Released by FDA

FDA has released the FDA-483 that was at the center of an Alvotech-received complete response letter (see earlier story) on its biosimilar BLA for AVT02, a monoclonal antibody that was being evaluated for biosimilarity and interchangeability to Abbott’s Humira (adalimumab). The letter cited inspection deficiencies at Alvotech's Reykjavik, Iceland manufacturing facility, which must be corrected before the therapy can be approved, according to the company.

The FDA-483 cites 13 inspectional observations. For example, the agency took issue with the company’s procedural control to ensure that incoming materials are adequately qualified, saying that it did not investigate a “progressively increasing trend of critical quality defects” identified for incoming (redacted) materials.

The agency also cited certain manufacturing areas that are not under control for bacteria and mold. The 483 said there is an “unacceptably high number of mold recoveries in the classified rooms” used for manufacture of certain drug substance and drug products. It notes that there have been 91 and 89 microbial excursions in 2020 and 2021, respectively. “The corrective and preventive actions (CAPA) implemented due to reoccurring microbial excursions were inadequate to avoid future occurrences of similar excursions,” it says.

Additionally, FDA says the company’s investigations of an unexplained discrepancy did not extend to other drug products that may have been
associated with the specific failure or discrepancy.

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