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FDA Issues Second CRL for Alvotech’s Adalimumab Biosimilar


Approval has been pushed back to June 28, 2023.

Tada Images/AdobeStock

Tada Images/AdobeStock

The US Food and Drug Administration (FDA) issued a second complete response letter (CRL) to Alvotech for its Biologics License Application (BLA) for its adalimumab biosimilar, AVT02, after re-inspecting the company’s Iceland-based manufacturing facility in March 2023. The CRL cited certain deficiencies with the facility, but no issues with the biosimilar itself or its safety and efficacy data.

Alvotech’s second BLA for AVT02 contains data to support approval as a biosimilar and additional information supporting potential interchangeability designation with the reference product (Humira; AbbVie) and is still under review by the FDA. The FDA has assigned a Biosimilar User Fee Amendment (BsUFA) goal date of June 28, 2023. The satisfactory outcome of the manufacturing facility reinspection will determine the FDA’s approval.

AVT02 is a citrate-free, high-concentration adalimumab biosimilar. The citrate-free formulation allows for decreased injection site pain for patients and the high-concentration formulation allows for a higher volume administration, requiring fewer doses overall. If approved with the interchangeability designation, it would be the only high-concentration adalimumab biosimilar to achieve interchangeability status. AVT02 also has the potential to be the ninth adalimumab biosimilar overall and fifth overall to receive interchangeability.

Alvotech plans to launch AVT02 in July 2023, when 8 other adalimumab biosimilars are also planned to launch. Assuming AVT02 is approved in time for the company to stick to its launch timeline, AVT02 would join Amjevita (Amgen), the first adalimumab biosimilar to enter the market and launch alongside Cyltezo (Boehringer Ingelheim), Hadlima (Organon/Samsung Bioepis), Hulio (Biocon Biologics), Yusimry (Coherus Biosciences), Abrilada (Pfizer), Hyrimoz (Sandoz), and Idacio (Fresenius Kabi).

Celltrion Healthcare, whose high-concentration adalimumab biosimilar (Yuflyma) is expected to be FDA-approved in May 2023 and launched in July 2023, is also seeking interchangeability designation.

Robert Wessman, chairman and CEO of Alvotech, noted that Alvotech will work with the FDA to resolve any remaining issues identified in the re-inspection.

Alvotech received its first CRL in September 2022 after an initial inspection of the manufacturing facility in Reykjavik. Same as the second CRL, certain “deficiencies” were identified by the FDA in the first inspection, which were not defined by Alvotech.

AVT02 is already approved in Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, and Saudi Arabia. Wessman and Alvotech are dedicated to bringing Alvotech’s AVT02 to patients in the US who can benefit from a high-concentration and interchangeable adalimumab biosimilar.


Alvotech provides regulatory update on AVT02 biologics license application. Alvotech. Published April 14, 2023. Accessed April 19, 2023. https://investors.alvotech.com/news-releases/news-release-details/alvotech-provides-regulatory-update-avt02-biologics-license

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