Shanghai Henlius Biotech has achieved a significant regulatory milestone with the FDA approval of two denosumab biosimilars, BILDYOS and BILPREVDA, for the treatment of osteoporosis and other bone-related conditions. The approval represents the company's sixth product cleared for overseas marketing and strengthens its position in the global biosimilars market.
FDA Approval Based on Comprehensive Comparative Studies
The FDA's approval was primarily based on a comprehensive review of comparative study data between HLX14 and the reference product, Prolia. HLX14 is a denosumab biosimilar independently developed by Shanghai Henlius Biotech, designed to demonstrate similarity to the reference biologics in terms of quality, safety, and efficacy.
The approved biosimilars are indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, along with other indications consistent with the reference biologics' label. The FDA has approved both products for eight indications related to osteoporosis and other bone conditions.
Strategic Partnership for Global Commercialization
The product names BILDYOS and BILPREVDA are registered in the United States under N.V. Organon, reflecting Shanghai Henlius Biotech's strategic partnership with Organon LLC for commercialization outside of China. This collaboration is expected to enhance the company's market position and expand its global reach in the biosimilars market.
Expanding Portfolio of Approved Products
With these latest approvals, Shanghai Henlius Biotech now has a total of six products approved for marketing overseas, demonstrating the company's growing presence in international markets. The biotechnology company, based in China, focuses on the development and commercialization of biosimilar products, with particular emphasis on treatments for various medical conditions including bone-related diseases.
The approval of these denosumab biosimilars addresses the treatment needs for osteoporosis, a condition that particularly affects postmenopausal women and represents a significant healthcare burden globally. The availability of biosimilar alternatives may provide additional treatment options for patients and healthcare providers managing osteoporosis and related bone conditions.
