Henlius Biotech Gets NMPA Nod for Denosumab Biosimilar

Shanghai Henlius Biotech said its denosumab biosimilar (HLX14) has been approved by China’s National Medical Products Administration (NMPA) for the treatment of postmenopausal osteoporosis. The approval came just 2 months after the investigational new drug application for HLX14 was accepted for review by the NMPA.

Osteoporosis affects almost 70 million Chinese over the age of 50 and is responsible for 687,000 hip fractures each year, according to the International Osteoporosis Foundation. . A large number of cases are concentrated in postmenopausal women and elderly patients. Osteoporosis can lead to a higher risk of fractures, which can greatly affect a patient’s quality of life.

“At present, the rate of medical consultation and standardized treatment of osteoporosis is still low globally,” and the continual growth of the patient population constitutes an urgent need for treatment options, Henlius officials said in a statement.

Henlius followed biosimilar guidance issued by China and the European Medicines Agency (EMA) to complete head-to-head studies analyzing comparative pharmacology, pharmacokinetics, and biosimilarity between HLX14 and reference denosumab (Prolia).

Denosumab is a recombinant anti-RANKL human monoclonal antibody (mAb) injection that blocks the binding of RANKL receptors that regulate bone resorption, which in osteoporosis exceeds the rate of bone formation. Denosumab retards bone resorption, thereby favoring bone formation over bone resorption, leading to increased bone mass and a reduced risk of fractures.

Recently, Henlius announced that its bevacizumab biosimilar (HLX04) met primary end points in a phase 3 trial comparing the safety, efficacy, and immunogenicity compared with the reference product (Avastin).

Growing Osteoporosis Drug Market

In May, Daewon Pharmaceutical of Republic of Korea launched its teriparatide biosimilar, Terrosa, also for the treatment of osteoporosis in men and postmenopausal women with a high risk of fractures. Terrosa was the first teriparatide biosimilar launched in the Republic of Korea and the first biosimilar for Daewon.

Terrosa was approved by the EMA in 2017 and launched in that market in 2019. It is also available in the United States but not as a biosimilar.

Pfenex also has an approved teriparatide molecule that serves as a follow-on product to reference teriparatide Forsteo. In the United States, the company submitted a 505(b)(2) application for approval rather than an abbreviated Biologics License Application.