The FDA has rejected Alvotech’s Humira biosimilar for the third time. Credit: Shutterstock / Jennie Book.

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Humira biosimilar AVT02, further delaying the company’s plans to launch the drug in a landmark year. 

The agency rejected the drug’s biologics licence application (BLA) over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland, according to Alvotech’s press release on 28 June.

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While the FDA did not make a note of any other deficiencies in the BLA, issues related to the Reykjavik facility need to be resolved to facilitate the drug’s potential approval.

This marks the second time that the FDA has rejected AVT02’s BLA this year. In April, the regulator issued a CRL to Alvotech, which also noted the deficiencies seen in the company’s Reykjavik plant. Prior to that, the company received a CRL from the FDA over deficiencies in the plant in September 2022.

Alvotech plans to resubmit the BLA, which will feature additional data aimed at securing an interchangeability designation. The resubmission would start another six-month review period.

Due to this, the company aims to explore options aimed at raising capital, which includes equity financing and the sale of convertible bonds. According to the announcement, Alvotech’s largest shareholder ATP Holdings has voiced its interest in offering up to $100m in proceeds from potential financing to the company.

AVT02 is a high-concentration biosimilar to Humira. Also known as adalimumab, AbbVie’s Humira has long been regarded as one of the key blockbuster drugs on the market that made billions of dollars since its US launch in 2003.

Humira is indicated for multiple conditions that include Crohn’s disease and rheumatoid arthritis. It is a monoclonal antibody that serves as a tumour necrosis factor (TNF) blocker.

AbbVie has long pursued an assertive legal strategy surrounding the drug and other companies had to negotiate for the earlier entry of their biosimilar to the US market.

While Amgen’s biosimilar Amjevita was approved by the FDA in September 2016, the company was not able to launch the product until January 2023. Indeed, although AVT02 is not approved in the US, the biosimilar has already been approved in Australia, Canada, and the EU.

More Humira biosimilars are set to reach the US market, including Boehringer Ingelheim’s Cyltezo and Pfizer’s Abrilada. Cyltezo will become available on 1 July, while Abrilada can launch as early as July.

The company is also developing a biosimilar to Janssen’s Stelara called AVT04. On 12 June, Alvotech and Teva Pharmaceuticals reached a settlement and licence agreement with Johnson & Johnson, which fully owns Janssen. The settlement granted a license entry date in the US for no later than 21 February 2025, as per the announcement.

In August 2020, Alvotech and Teva announced their strategic partnership to commercialise Alvotech’s biosimilars in the US.