Biocon and Alvotech Release Statements on FDA Inspections

On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia.  The inspections took place between August 11 and August 30, 2022.  The inspections were triggered by three preapproval inspections for Biocon’s bevacizumab (proposed biosimilar of Roche’s AVASTIN), rh-insulin, and insulin aspart, and a capacity expansion inspection for Biocon’s trastuzumab (biosimilar of Genentech’s HERCEPTIN).

As a result of the inspections, the FDA issued Form 483s, or “Inspectional Observations,” with 11 observations for each of the two Bengaluru sites and 6 observations for the Malaysia site.  According to Biocon, the FDA’s observations “primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools to aid risk assessment & investigations and other procedural & facility upgrades.”  Biocon noted its intent to submit timely Corrective and Preventive Action Plans (CAPA) to the FDA and stated, “[w]e do not expect the outcome of these inspections to impact the current supply of our products.”

On September 5, 2022, Alvotech announced that it received a post-application action letter related to the FDA’s assessment of its manufacturing facility in Reykjavik, Iceland in March 2022 in relation to Avotech’s BLA for AVT02, a monoclonal antibody that is being evaluated for biosimilarity and interchangeability to HUMIRA (adalimumab).  Mark Levick, CEO of Alvotech, stated that “Alvotech looks forward to addressing the deficiencies outlined in the post-application action letter and continuing to work with the FDA to close out the facility inspection. We aim to satisfactorily address the issues before the Biosimilar User Fee Act (BSUFA) goal date for the interchangeable biosimilar BLA in December.”