FDA Issues Complete Response for Alvotech’s Biosimilar of Stelara


The regulatory agency found deficiencies in its inspection of Alvotech’s Reykjavik, Iceland, facility. The company plans to resubmit its application once these are addressed.

The FDA has issued a complete response letter (CRL) for Alvotech’s biologics license application (BLA) for AVT04, a biosimilar candidate to Johnson & Johnson’s Stelara (ustekinumab). AVT04 and Stelara are monoclonal antibodies that binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. Stelara is approved to treat patients with moderate-to-severe psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.

The regulatory agency found deficiencies in its inspection of the Alvotech’s Reykjavik, Iceland, facility. No other deficiencies in the application were noted by the FDA. Alvotech intends to resubmit the BLA for AVT04, which would likely trigger a six-month review period and a new Biosimilar User Fee Act (BsUFA) goal dat

In June 2023 Alvotech and Teva, which will market AVT04 in the United States, reached a settlement and license agreement with Johnson & Johnson, that grants an entry date for AVT04 in the U.S. no later than Feb. 21, 2025.

Related: Fresenius Kabi Reaches Agreement with J&J over Stelara Biosimilar

In August, J&J also reached an agreement with Fresenius Kabi and Formycon over their proposed biosimilar to Stelara. This settlement allows Fresenius Kabi and Formycon to launch their product no later than April 15, 2025. This follows a settlement J&J reached in May 2023 with Amgen, which will allow Amgen’s ustekinumab biosimilar to launch no later than Jan. 1, 2025.

Alvotech’s Stelara biosimilar was approved in Japan in September 2023. Fuji Pharma will market the product in that country.

Additionally, Alvotech is awaiting approval for its application to the FDA for ATV02, a biosimilar of AbbVie’s Humira (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date is Feb. 24, 2024. If approved, it will also be marketed by Teva.

Alvotech is also developing biosimilars of Prolia/Xgeva (denosumab) for osteoporosis, Simponi/Simponi Aria (golimumab) for inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, Eylea (aflibercept) for macular degeneration and macular edema, and Entyvio (vedolizumab) for colitis and Crohn’s disease.

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