Denosumab Biosimilar Updates

Celltrion Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA. According to the report, once CT-P41 is approved in the U.S., “it is expected to secure the status of an interchangeable biosimilar, enabling substitution prescriptions for the original products, thereby rapidly penetrating the market and increasing accessibility for patients.” Celltrion’s BLA for CT-P41 is the second publicly reported application to the FDA for a denosumab biosimilar, following Sandoz’s application, which was accepted by the FDA in February 2023.

Lotus/Intas Strategic Partnership: On December 11, 2023, Lotus and Intas announced a strategic partnership to distribute and commercialize denosumab biosimilar in South Korea, Taiwan, and multiple Southeast Asia markets. The announcement notes that denosumab is sold as PROLIA for osteoporosis related ailments and as XGEVA for preventing skeletal-related events in individuals with multiple myeloma and those with bone metastases from solid tumors and for giant cell tumors of bone in cases where surgical resection is impractical or likely to lead to severe morbidity. The announcement states that according to IQVIA data for the 12 months ended December 2022, the regions covered by the agreement had PROLIA and XGEVA sales of 202 million USD and 45 million USD, respectively.