Daewoong and Celltrion Pharm to co-promote osteoporosis drug CT-P41

Daewoong Pharmaceutical said Thursday that it has signed an agreement with Celltrion Pharm to jointly market CT-P41, a biosimilar of the osteoporosis treatment Prolia (denosumab).

Under the agreement, Daewoong Pharmaceutical and Celltrion Pharm will jointly promote CT-P41 for general hospitals and clinics nationwide. It is scheduled to launch in the first half of 2025.

CT-P41 is an osteoporosis treatment developed by Celltrion as a biosimilar of the original drug Prolia, the patent of which expires next March. CT-P41's main active ingredient, denosumab, targets the RANKL (Receptor Activator of Nuclear factor Kappa-B Ligand) protein, which forms and activates osteoclasts. This reduces the activity of bone-destroying osteoclasts and inhibits bone resorption.

It provides six months of protection with a single injection and has a high compliance rate.

Celltrion demonstrated the efficacy and safety of CT-P41 in a global phase 3 clinical trial presented at the American Society for Bone and Mineral Research (ASBMR) general meeting in September. The study analyzed 78 weeks of detailed data and met the primary efficacy endpoint of equivalence between CT-P41 and the originator treatment arm.

Patients who received CT-P41 52 weeks after receiving the originator drug also demonstrated efficacy and safety at 78 weeks.

“With this agreement, Daewoong Pharmaceutical's strong sales and marketing capabilities and Celltrion's excellent biosimilar technology will work in synergy to dominate the osteoporosis treatment market,” Daewoong Pharmaceutical CEO Lee Chang-jae said. “We will do our best to reduce the risk of fractures and improve the quality of life of osteoporosis patients in Korea through CT-P41, which has a prescription market of 160 billion won.”

Cellion Pharm CEO Yoo Young-ho said, “CT-P41 recently unveiled its phase 3 Week 78 results at the World Osteoporosis Congress, once again confirming similarity in efficacy, pharmacodynamic equivalence, and safety compared to the original. We will do our best to ensure a stable supply of high-quality treatments once the ongoing approval process is completed.”