The US FDA has rejected Alvotech and Teva’s biosimilar of J&J bestseller Stelara citing deficiencies at a site in Reykjavik, Iceland.

Dan Stanton, Managing editor

October 13, 2023

2 Min Read
Alvotech: Iceland plant leads to FDA rejection of Stelara biosimilar
DepositPhotos/aallm

The US FDA has rejected Alvotech and Teva’s biosimilar of J&J bestseller Stelara (ustekinumab) citing manufacturing deficiencies at a site in Reykjavik, Iceland.

In 2022, psoriasis, Crohn’s disease, and ulcerative colitis monoclonal antibody Stelara brought Johnson & Johnson $6.4 billion in US sales. But last month, Stelara’s patent protections began to expire opening the doors to biosimilar competition.

One such product looking to take a slice of the market is AVT04, a biosimilar being developed by Alvotech and Teva. However, the molecule has hit a setback with the US Food and Drug Administration (FDA) issuing a complete response letter (CRL) rejecting the application this week.

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DepositPhotos/aallm

“As expected, the CRL noted that certain deficiencies, which were conveyed following the FDA’s inspection of the company’s Reykjavik facility that concluded in March 2023, must be satisfactorily resolved before the application can be approved,” Alvotech wrote in a statement. “No other deficiencies in the application were noted by the FDA.”

The firm intends to resubmit the Biologics License Application (BLA) for AVT04 in due course, which it says would likely trigger a six-month review period and a new Biosimilar User Fee Act (BsUFA) goal date.

“AVT04 has recently been approved in Japan, and other marketing applications for AVT04 are currently awaiting approval in other major markets,” Robert Wessman, Alvotech CEO, said. “Based on our latest interactions with the FDA we are currently expecting that the agency will reinspect our facility in the beginning of next year.”

The competitive advantage of being one of the first to market with a biosimilar has been well documented, and such a delay could allow other Stelara biosimilars to enter the market ahead of Alvotech/Teva.

However, there is some breathing space for Alvotech and Teva as rival developers Amgen and Formycon/Fresenius Kabi have both settled lawsuits with J&J to delay their respective biosimilars to early 2025, while Sandoz – which partnered with Samsung Bioepis – is expected to launch its version on a similar timescale.

For Alvotech, the news comes months after the FDA rejected another biosimilar based also on an inspection that took place at the Reykjavik plant in March. AVT02, a biosimilar to AbbVie’s Humira (adalimumab) missed out on its intended June launch after receiving a CRL the month before due to a manufacturing deficiency in Reykjavik. A prior inspection in March 2022 resulted in the issuance of an earlier CRL noting “certain deficiencies” in the manufacturing of AVT02.

About the Author(s)

Dan Stanton

Managing editor

Journalist covering the international biopharmaceutical manufacturing and processing industries.


Founder and editor of Bioprocess Insider, a daily news offshoot of publication Bioprocess International, with expertise in the pharmaceutical and healthcare sectors, in particular, the following niches: CROs, CDMOs, M&A, IPOs, biotech, bioprocessing methods and equipment, drug delivery, regulatory affairs and business development.


From London, UK originally but currently based in Montpellier, France through a round-a-bout adventure that has seen me live and work in Leeds (UK), London, New Zealand, and China.

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