Alvotech

FDA approves Fresenius Kabi’s and Formycon’s Otulfi, a biosimilar to Stelara, for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi’s fourth biosimilar approval by the FDA, aligning with its Vision 2026 strategy to expand its biopharma market presence.

FDA approved Fresenius Kabi and Formycon's Otulfi™ (ustekinumab-aauz) as the fourth biosimilar of Janssen/Johnson & Johnson’s Stelara® (ustekinumab) on September 27, 2024, following Amgen’s Wezlana™, Alvotech/Teva’s Selarsdi™, and Samsung Bioepis/Sandoz’s Pyzchiva®. Otulfi™ received EU approval on the same day. Under settlement agreements, Otulfi™, Wezlana™, Selarsdi™, and Pyzchiva® can enter the U.S. market by February 2025. Numerous Stelara® biosimilars await FDA approval, with no pending patent disputes.

Fresenius Kabi and Formycon receive FDA approval for Otulfi, a Stelara biosimilar, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Otulfi is the fourth Stelara biosimilar approved in the US, following Amgen’s Wezlana, Alvotech and Teva’s Selarsdi, and Samsung Bioepis and Sandoz’s Pyzchiva. Stelara sales are expected to drop to $1.2bn by 2030 due to biosimilar competition.

FDA approves Fresnius Kabi and Formycon’s ustekinumab biosimilar, ustekinumab-aauz (Otulfi), for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresnius Kabi’s fourth biosimilar product in the U.S. market, reflecting their commitment to broadening their biopharma portfolio globally.

Evernorth Health Services will offer a private-label biosimilar of Stelara (ustekinumab) starting in early 2025, with a price over 80% lower than Stelara's list price. The biosimilar will be available for $0 out of pocket for eligible patients through Accredo, potentially saving individual patients around $4,000 per year. Evernorth has already seen strong interest in its private-label Humira biosimilar, with over 25% of eligible Accredo patients using it.

The biosimilars market is expanding, with the global market projected to hit $43.8 billion by 2024 and exceed $100 billion in a decade. Recent FDA and EMA approvals include biosimilars for Johnson & Johnson’s Stelara and Bayer’s Eylea, following patent expirations. Notable approvals include Pyzchiva, Ahzantive, Yesafily, Opuviz, Hercessi, Selarsdi, Wyost, Jubbonti, Simlandi, and Uzpruvo, targeting various conditions and expected to launch by 2025.

Samsung Bioepis's Pyzchiva, a biosimilar to J&J's Stelara, approved by FDA for treating severe plaque psoriasis, psoriatic arthritis, Crohn’s, and ulcerative colitis. Set for U.S. commercialization by Sandoz, with competition from Alvotech, Teva, and Amgen biosimilars starting February 2025. J&J's Stelara sales hit $2.4B in Q1 2024, below the $2.6B estimate.

Alvotech and Teva's Selarsdi™, a biosimilar to Stelara®, was FDA approved on April 16, 2024, with a U.S. market entry by February 21, 2025. This marks the second Stelara® biosimilar approval, following Amgen's Wezlana™. Four other Stelara® biosimilars are pending approval. Stelara®'s 2023 U.S. sales were ~$6.97B.

Alvotech and Teva announced FDA approval of SELARSDI, a biosimilar to Johnson & Johnson’s STELERA®, for treating moderate to severe plaque psoriasis and psoriatic arthritis. SELARSDI, developed by Alvotech and commercialized by Teva, is the second ustekinumab biosimilar approved by the FDA, following Amgen’s WEZLANA.