Celltrion Inc

Phase 3 trial data for biosimilar CT-P41 (Celltrion) in postmenopausal osteoporosis showed equivalence to denosumab in efficacy, pharmacodynamics, pharmacokinetics, and safety, with well-tolerated transitions from reference product to biosimilar.

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Mirikizumab (Omvoh) showed improved outcomes in Crohn's disease patients with previous standard therapy failure, with 38% meeting composite endpoint of PRO clinical response at week 12 and endoscopic response at week 52 vs. 9% on placebo (P<0.0001). Mirikizumab also met primary endpoint of PRO clinical response at week 12 and CDAI clinical remission at week 52 in 45.4% vs. 19.6% on placebo (P<0.0001). The study highlights IL-23's role in Crohn's disease pathogenesis and suggests mirikizumab's favorable benefit-risk profile.

Celltrion initiated phase 3 trials for CT-P44, its biosimilar to Janssen's Darzalex (daratumumab), targeting multiple myeloma. The global trial, submitted to the European Medicines Agency, will compare CT-P44 with Darzalex in 486 patients. Celltrion plans to expand trials to the U.S. and Korea, aiming to build a robust oncology portfolio, including ADCs and immuno-oncology drugs.

Celltrion's Remsima, the world's first biosimilar monoclonal antibody, is expected to exceed 1 trillion won in sales in 2024, becoming the first Korean drug to hit this milestone. Remsima, approved by Europe in 2013 and the FDA in 2016, is available in over 100 countries and is cheaper than the original drug with the same efficacy, used for treating chronic diseases like rheumatoid arthritis.

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Merck's subcutaneous Keytruda showed similar characteristics to IV formulation in a Phase 3 trial. The company plans to discuss trial data with FDA and other regulators. Keytruda's U.S. patent expires in 2028, opening the door to biosimilar competitors. Rival Roche has FDA approval for subcutaneous Tecentriq, while Bristol Myers awaits FDA decision on subcutaneous Opdivo. Merck aims to sustain Keytruda's revenue, which reached nearly $22 billion in the first nine months of 2024, by transitioning to a more convenient subcutaneous shot.

Celltrion disclosed global Phase 3 data for biosimilars CT-P47 and CT-P41 at the 2024 ACR Annual Meeting, showing efficacy and safety. CT-P47's 52-week trial on RA patients and CT-P41's 78-week trial on osteoporosis patients met equivalence criteria. Both biosimilars are under approval worldwide.

Celltrion presented Phase III RCT data for CT-P41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocilizumab) at ACR Convergence 2024, showing comparable efficacy and safety profiles to their reference products in treating osteoporosis and rheumatoid arthritis, respectively.

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