Celltrion Inc

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.

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Hyundai ADM Bio has voluntarily withdrawn its IND application for Penetrium™ with docetaxel to strategically refocus on immunotherapy combinations, with plans to submit a new IND application this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

Celltrion will present six abstracts at the 2025 Digestive Disease Week, featuring post-hoc analyses and real-world evidence for ZYMFENTRA®, the first FDA-approved subcutaneous infliximab.

• Preclinical data presented at AACR 2025 demonstrates ABP-102/CT-P72's superior tumor selectivity and reduced toxicity compared to existing HER2-targeted T-cell engagers. • The novel bispecific antibody showed up to two-fold greater tumor suppression versus runimotamab biosimilar while maintaining safety at doses 180 times higher than the parental antibody's maximum tolerated dose. • Developed through Abpro and Celltrion's strategic partnership, ABP-102/CT-P72 targets HER2-positive cancers that represent up to 30% of breast, gastric, pancreatic, and colorectal malignancies.

• Recent clinical trials demonstrate that emerging therapies including dupilumab, remibrutinib, and barzolvolimab achieve complete response rates of 28-51% in patients with chronic spontaneous urticaria (CSU) who are resistant to standard treatments. • Remibrutinib, a novel oral Bruton tyrosine kinase inhibitor, showed rapid improvement in urticaria control as early as week 2 in phase 3 REMIX trials, with approximately 64% of patients achieving well-controlled disease by week 24. • Long-term safety data for omalizumab reveals virtually no risk of anaphylaxis or serum sickness after 2.5 million injections over two decades, establishing its continued importance in the treatment landscape for severe allergic conditions.

Amgen and Fresenius Kabi have settled their BPCIA litigation regarding Fresenius's denosumab biosimilar FKS518, with the New Jersey District Court entering a dismissal order on March 7, 2025.

Celltrion's infliximab biosimilar, previously marketed as Inflectra®, will be rebranded as Remdantry™ in Canada starting April 1, 2025, while maintaining the same formulation and Drug Identification Number.

FDA regulatory actions in Q1 2025 include approval of Celltrion's denosumab biosimilars and Fast Track designation for CAR-T therapies targeting lupus, expanding treatment options for autoimmune conditions.

BasgenBio secures a 1 billion won ($684,090) deal with Novartis to implement AI-driven digital twin technology for predicting side effects in breast cancer patients.