Celltrion Inc. advanced its push into the biosimilars market as its knockoff versions of Roche’s Actemra and Amgen’s Prolia demonstrated comparable effectiveness to the original drugs in late-stage trials.
The South Korean drugmaker presented results at the American College of Rheumatology meeting showing its Actemra copy, CT-P47, matched the reference drug in treating rheumatoid arthritis patients over 52 weeks. The study of 471 patients revealed similar efficacy and safety profiles when some participants switched from the original drug to the biosimilar at week 24.
In a separate 78-week trial involving 479 postmenopausal women with osteoporosis, Celltrion’s version of Prolia, known as CT-P41, showed equivalent results to the original medication. The company said patients who switched to CT-P41 at week 52 maintained similar effectiveness and safety compared to those who stayed on either the biosimilar or reference drug.
Both biosimilars are currently under regulatory review in the U.S. and Europe. The successful trials bolster Celltrion’s efforts to capture market share from established treatments, though launch timelines remain uncertain pending approvals.
The two products represent key elements of Celltrion’s pipeline expansion strategy in the growing biosimilars sector.
