Amgen, Inc.

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.

Volastra Therapeutics announced FDA Fast Track designation for VLS-1488, a KIF18A inhibitor for platinum-resistant high-grade serous ovarian cancer, reflecting its potential to address unmet medical needs.

Pharma companies like Novo Nordisk, Viking Therapeutics, Amgen, CRISPR Therapeutics, and Moderna are set to announce clinical trial results for next-gen weight loss drugs, cancer and autoimmune therapies, and potential new products beyond COVID-19 vaccines by year-end.

DPHARM 2024 focused on innovations in clinical trials, featuring keynotes on ROI, DCTs, AI, and patient perspectives. Panels discussed efficiency, AI use, and ecosystem approaches. Outside-industry speakers offered unique insights. Technologists showcased patient-centric services. Sponsors highlighted innovation and collaboration. DPHARM Idol Disrupt finalists presented disruptive technologies, with Power winning for its patient-matching platform. The event aimed to improve clinical trials for faster, more efficient medicine delivery.

Luxa Biotechnology appoints Keith Dionne, Ph.D. as CEO to advance RPESC therapy for dry AMD/GA, aiming to restore vision for patients lacking treatment options.

Amgen partners with La La Anthony to encourage open dialogue about plaque psoriasis, highlighting the importance of discussing symptoms and treatment options with doctors.

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.