Teva Pharmaceutical Industries

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.

Teva Pharmaceutical Industries launched the first generic version of Sandostatin LAR Depot in the U.S., used for treating acromegaly and carcinoid syndrome. The generic drug aims to provide more affordable treatment, with the brand-name version having annual sales of $826 million. Teva shares were down 2.6% at $254.81.

Teva Pharmaceutical Industries launched its generic Sandostatin LAR, an acromegaly treatment, with potential $200 million annual revenue. BofA Securities reaffirmed its Buy rating and $22.00 price target. Teva's generic is the first to market, facing competition from Viatris. The launch is expected to boost Teva's financials in 2024-25, supported by other positive portfolio results. Teva also settled an $80 million opioid litigation and saw a 11% revenue growth in Q2 2024.

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.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.

Teva Pharmaceuticals launches the first generic version of Sandostatin LAR Depot in the U.S., indicated for treating acromegaly and severe diarrhea in carcinoid syndrome. The original drug had annual sales of $826 million as of July 2024.

MP Nigdelis received honoraria from RG Ärztefortbildung GmbH and travel grants from Organon and Gedeon Richter. M Doerk received travel grants from Gedeon Richter, Organon, and Eisai, and is a member of DGGG, AGE, and Deutsche Gesellschaft für Senologie. S Burghaus received honoraria from FOMF and is a member of DGGG, AGEM, AGE, Stiftung Endometriose Forschung, AGUB, AGO, and DKK. M Sillem, CEO of EuroEndoCert Gmbh, received payments from Bayer, Gedeon Richter, Hologic, and EndoHealth. B Haj Hamoud received travel grants from Gedeon Richter, Astrazeneca, Johnson & Johnson, and Storz, and is a member of DGGG, AGE, and Stiftung Endometriose Forschung. EF Solomayer receives grants from the University of Saarland, Storz, and Erbe, and fees from Roche, Pfizer, Celgene, Amgen, Astra Zeneca, Esai, Johnson & Johnson, Novartis, Tesaro, Teva, Medac GmbH, MSD, Vifor, Gedeon Richter, Takeda, and AGE, among others. GL Olmes received grants from AstraZeneca, Universitätsklinikum Freiburg, and RG Ärztefortbildung GmbH, and is a member of DGGG, AGE, and AGEM, with scientific collaboration with Karl Stotz.