Sandoz Group AG

Milan's IP court shake-up impacts proceedings; Italian Supreme Court's Bolar exemption interpretation affects pharma litigation. Trevisan & Cuonzo and Bird & Bird lead in patent disputes, with firms like Hogan Lovells and Simmons & Simmons also prominent. Italian IP boutiques maintain strong presence, often combining academic work with litigation.

EMA's CHMP adopted positive opinions for Sandoz's AFQLIR and Samsung-Biogen's OPUVIZ aflibercept biosimilars, both recommended for treating neovascular AMD, macular oedema, DME, and myopic CNV.

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.

AJNA BioSciences, based in Colorado, is developing a full-spectrum psilocybin 'novel antidepressant' and aims to capture a high single-digit percentage of the growing psychedelic drugs market, estimated to grow by more than 12% annually through 2027. The company is standardizing botanical materials to meet strict FDA guidelines and is the first biotech company working with botanicals under a DEA Schedule-1 license. AJNA's research team, led by scientists from Harvard, Johns Hopkins, and NYU, is conducting clinical trials similar to large drug manufacturers, focusing on FDA approvals to ensure market acceptance and insurance reimbursement. The company is currently raising capital through a crowdfunding round on Wefunder.

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.

FDA approves Otulfi, a fourth Stelara biosimilar, for chronic inflammatory diseases including Crohn’s and ulcerative colitis, expected to be available in the U.S. by February.

FDA approved Accord’s HERCESSI (trastuzumab-strf) 420 mg for HER2-overexpressing cancers, following its 150 mg approval. Amgen’s PAVBLU (aflibercept-ayyh), a biosimilar to EYLEA®, was also approved for eye conditions, marking the fifth aflibercept biosimilar approval.