Celltrion Inc

Keytruda, a cancer drug, achieved $25 billion in global sales, treating 40 cancers in the US and 17 in India. Its mechanism activates the immune system to fight cancer cells, categorized as immunotherapy. Despite high costs, it has shown remarkable results in some cases, prompting Indian drugmakers to develop affordable biosimilars as patents expire.

Federal Circuit denies Regeneron's request for injunction pending appeal against Amgen's biosimilar aflibercept launch, expediting the case for January 2025 oral arguments.

Celltrion plans to establish a wholly-owned CDMO subsidiary to enhance market presence, following a merger with Celltrion Healthcare that improved COGS ratio. Zympentra, a new autoimmune drug, rapidly expanded coverage in the U.S. and aims for 1 trillion won in sales next year. The CDMO subsidiary will leverage Celltrion's antibody development and production expertise, with full-scale activities starting next year. Chairman Seo Jung-jin projects Zympentra could reach 5 trillion won in sales within three years.

Tulisokibart maintained clinical and endoscopic improvements in IBD patients through week 50 in phase II trial extensions, with 48% of ulcerative colitis patients and 56% of Crohn's disease patients achieving clinical remission. The drug was well-tolerated with no identified safety signals.

Regeneron loses bid to block Amgen's Eylea biosimilar, plans appeal; Prime Therapeutics adds low-cost Humira biosimilars; FDA and EMA accept Alvotech's denosumab biosimilar for review.

Dong-A ST received FDA approval for Imuldosa, a Stelara biosimilar, amidst a crowded market of approved but unlaunched biosimilars. Stelara's sales are expected to decline post-2023 patent expiry, with biosimilars like Amgen's Wezlana and Samsung Bioepis's Pyzchiva set to launch in 2025. Stelara, an IL-12/IL-23 inhibitor, treats psoriatic arthritis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.

Competition authorities are expanding their review of pharmaceutical deals, focusing on whether existing tools for identifying and remedying competition issues are sufficient. The Multilateral Pharmaceutical Merger Task Force explores new enforcement approaches, considering factors like innovation effects, conglomerate effects, and coordinated effects. Authorities in regions like the EU, US, and APAC assess theories of harm, market definitions, and legal standards, with remedies often involving divestitures to ensure market competition.

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.