Celltrion Inc

The FDA approved tocilizumab-anoh (Avtozma) IV formulation on August 6, 2025, for treating cytokine release syndrome in patients aged 2 years and older.

Celltrion has been named the preferred bidder for a large-scale biologics manufacturing facility in the US, with a final agreement expected in early October.

A McMaster University-led international study analyzed 93 randomized controlled trials involving over 11,000 participants to identify the most effective treatments for chronic hives.

The FDA has approved Omlyclo (omalizumab-igec) as the first biosimilar interchangeable with Xolair for treating allergic asthma, chronic rhinosinusitis with nasal polyps, chronic urticaria, and food allergies.

Celltrion has initiated development of a biosimilar version of Merck's pembrolizumab (Keytruda), starting work 10 years ahead of the drug's patent expiration in June 2028.

Infliximab biosimilar initiation among pediatric IBD patients increased gradually from 1% in 2018 to nearly 42% in 2023 across 73 centers in the ImproveCareNow Network.

Regeneron filed a new patent infringement complaint against Amgen on June 17, 2025, asserting U.S. Patent No. 12,331,099 covering a stable liquid ophthalmic formulation without buffer requirements.

CT-P47, a tocilizumab biosimilar, showed comparable efficacy and safety to reference Actemra over 52 weeks in a phase 3 trial involving 444 rheumatoid arthritis patients.

The three largest U.S. pharmacy benefit managers have excluded nearly all marketed Humira biosimilars from their 2025 standard formularies, marking a dramatic shift from 2024 when eight products were covered.

Hyundai ADM Bio has voluntarily withdrawn its IND application for Penetrium™ with docetaxel to strategically refocus on immunotherapy combinations, with plans to submit a new IND application this month.