Samsung Bioepis said Tuesday it has initiated the phase 3 clinical trial of SB16 (Denosumab), a Prolia biosimilar treating osteoporosis.

The company began to conduct the trial in November, comparing the efficacy and safety of SB16 with the original drug on 432 post-menopausal osteoporosis patients in six countries. Prolia is Amgen’s treatment for skeletal diseases, osteoporosis and bone loss of cancer patients. Its sales totaled 3.1 trillion won ($2.83 billion) last year.

Phase 1 clinical began in October to check pharmacokinetics, safety and immunogenicity on healthy participants. The company accelerated the development process using the “overlap” strategy, which conducts the phase 3 trial on actual patients simultaneously. 

The related contents were published on the global clinical website, clinicaltrials.gov.

“We will speed up efforts to complete the clinical trials of SB16 to develop biosimilar drugs that would benefit more patients,” a Samsung Bioepis official said.

Samsung Bioepis has nine biosimilar pipelines. As SB16 has entered phase 3 trials, all the three biosimilar pipelines under development are undergoing the final phase.

Samsung BioEpis exports three autoimmune disease treatments (SB2, SB4 and SB5) and two anti-cancer drugs (SB3 and SB8) to Europe, and its ophthalmic disease treatment biosimilar SB11 has completed development. It is undergoing the screening process in the U.S. and Europe to win permissions.