Samsung Bioepis Reveals Clinical Data for Prolia Biosimilar 'SB16' for the First Time

Biosimilar of Skeletal Disease Treatment 'Prolia'
Used for Osteoporosis and Other Treatments
Phase 1 and 3 Clinical Trial Results Released
Equivalence in Efficacy and Safety Confirmed

Samsung Bioepis announced on the 16th that it has for the first time disclosed the Phase 1 and Phase 3 clinical trial results of the Prolia (active ingredient denosumab) biosimilar 'SB16' at the annual meeting of The American Society for Bone and Mineral Research (ASBMR), held from the 13th to the 16th (local time) in Vancouver, Canada.

Exterior view of Samsung Bioepis headquarters. [Photo by Samsung Bioepis]

Prolia is a treatment for skeletal and endocrine diseases developed by Amgen in the United States, used for treating osteoporosis and bone loss in cancer patients. Its global sales reached approximately 4.6 trillion KRW last year.

Since October 2020, Samsung Bioepis has been conducting Phase 1 clinical trials of SB16, and in December of the same year, initiated Phase 3 clinical trials involving actual patients, employing an 'overlap' strategy to conduct Phase 1 and Phase 3 trials simultaneously. This overlap strategy allows for concurrent follow-up clinical trials, thereby accelerating the development process.

Samsung Bioepis conducted Phase 1 clinical trials of SB16 on 168 healthy adult males, evaluating pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity between SB16 and the original drug. According to the abstract, the primary pharmacokinetic endpoints of Phase 1 met all pre-defined equivalence criteria between groups. This confirmed biological equivalence in terms of pharmacokinetics, and pharmacodynamics and safety were also found to be similar.

Additionally, Samsung Bioepis conducted Phase 3 clinical trials of SB16 on 457 postmenopausal osteoporosis patients, comparing efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity between SB16 and the original drug.

The primary efficacy endpoint of Phase 3, the percentage change from baseline in lumbar spine bone mineral density at 12 months post-dosing, was 5.6% for SB16 and 5.3% for the original drug in the overall population. In the per-protocol population, SB16 showed a 5.7% change, and the original drug showed 5.3%. The difference between SB16 and the original drug met the pre-defined equivalence criteria, confirming equivalent efficacy between the two groups.

Furthermore, the percentage change from baseline in hip bone mineral density was 3.5% for SB16 and 3.2% for the original drug. The percentage change from baseline in femoral neck bone mineral density was 2.8% for SB16 and 2.3% for the original drug.

The incidence and distribution of adverse reactions were also found to be similar through the Phase 3 clinical trials. In conclusion, Samsung Bioepis explained that efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety between SB16 and the original drug were confirmed to be similar.

Hong Il-seon, Head of the Product Evaluation (PE) Team at Samsung Bioepis, said, "We announced the biological equivalence between SB16 and the original drug at this ASBMR meeting," adding, "We will continue to strive to improve patient access to high-quality biopharmaceuticals."

This content was produced with the assistance of AI translation services.