Alvotech’s BLA for AVT02 receives a comprehensive response letter from the US FDA.

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The US Food and Drug Administration (FDA) has responded completely to Alvotech’s Biologics Licence Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira (adalimumab), according to a press release from the international biotech company Alvotech. The FDA’s reinspection of the company’s Reykjavik plant, which finished on March 17, 2023, revealed a number of issues that needed to be addressed before the application could be accepted, according to the CRL. The FDA didn’t find any other issues with the application. Alvotech sent the FDA thorough responses to the inspection observations on April 3, 2023, and is now awaiting word from the organisation evaluating those responses.

The FDA is still reviewing Alvotech’s second BLA for AVT02, which includes evidence to support biosimilar approval as well as additional information supporting potential interchangeability designation. A goal date for the Biosimilar User Fee Amendment (BsUFA) is June 28, 2023. The facility reinspection must have a satisfactory outcome in order to receive permission. Robert Wessman, chairman and CEO of Alvotech, said, “We look forward to working with the FDA to resolve any outstanding issues identified in the reinspection.” We are dedicated to producing AVT02 for patients in the US, especially as a potentially different Humira biosimilar that offers an interchangeable, high-concentration formulation.

The 27 EU member states, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, and Saudi Arabia have all authorised AVT02 as a biosimilar of Humira (adalimumab). AVT02 is a monoclonal antibody. Currently, it is marketed in Canada and sixteen European nations. Dossiers are being examined in a number of nations, including the US.

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