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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.
FDA Approves Xolremdi for Ultra Rare Immune Disorder
April 29th 2024Xolremdi is the first therapy for WHIM syndrome, which can cause recurrent lung infections and papillomavirus-related warts. It’s available in two doses: 400 mg for an annual cost of $496,400 and 300 mg for an annual cost of $372,300.
FDA Approves Pfizer’s Gene Therapy Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.
