AVT02 is biosimilar to Humira, which is indicated to treat inflammatory diseases including rheumatoid arthritis. Credit: Towfiqu barbhuiya on Unsplash.

Alvotech has from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for AVT02, a biosimilar to Humira (adalimumab).

The CRL stated that the BLA application cannot be approved until deficiencies identified at the company鈥檚 manufacturing facility in Reykjavik, Iceland, are satisfactorily resolved.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile 鈥� free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The FDA performed an inspection of the Reykjavik site in March 2022 and found deficiencies there. These were highlighted in the CRL to the initial BLA for AVT02 in September 2022.

The regulator re-inspected the Reykjavik facility in March 2023 and again reported deficiencies. In April, Alvotech responded to the FDA鈥檚 observations and is awaiting their reply.

Alvotech chairman and CEO Robert Wessman said: 鈥淲e look forward to working with the FDA to resolve any outstanding issues identified in the re-inspection.

鈥淲e are committed to manufacturing AVT02 for patients in the United States, especially a potentially differentiated Humira biosimilar that provides a high-concentration formulation and is interchangeable.鈥�

AVT02 is a monoclonal antibody approved as a biosimilar to Humira (adalimumab), a prescription drug used to treat rheumatoid arthritis and numerous other inflammatory diseases.

It has already been approved in the 27 European Union member countries, Switzerland, Australia, Iceland, Saudi Arabia, Canada, Norway, Lichtenstein and the UK.

The antibody is currently marketed in 16 countries in Europe, and also in Canada.

The second BLA for AVT02 included data to support approval as a biosimilar, along with additional information that confirms potential interchangeability between AVT02 and Humira.

In January 2023, Alvotech and Bioventure received manufacturing and distribution approval for AVT02 from the Saudi Food and Drug Authority (SFDA).