HuonsLab "Prolia Biosimilar Confirmed Equivalent Efficacy in Animal Tests"

[Asia Economy Reporter Myunghwan Lee] Huons Lab announced on the 7th that the biosimilar of the osteoporosis treatment drug 'Prolia,' 'HLB3-013' (active ingredient Denosumab), has been confirmed to have equivalent efficacy to the original drug Prolia in non-clinical animal efficacy tests.

This result was obtained from overseas clinical trial contract research organization (CRO) using an osteoporosis-induced mouse model. Huons Lab explained that when the original drug and the developing HLB3-013 were administered at the same dose, bone analysis showed that HLB3-013 demonstrated equivalent efficacy in suppressing osteoporosis symptoms across various factors compared to the original drug.

Prolia is a drug that binds to RANKL, an essential protein for osteoclasts that destroy bone, thereby inhibiting the formation, function, and survival of osteoclasts to prevent bone destruction. It is used for increasing bone density in osteoporosis patients and is approaching patent expiration in 2025. Prolia’s effect lasts for six months with a single administration.

In 2022, Prolia recorded global sales of approximately $3.6 billion (about 4.55 trillion KRW), with domestic sales reaching around 100 billion KRW. According to pharmaceutical research firm Kotelis, the global Prolia market is expected to grow at an average annual rate of 5.6%, reaching approximately 7.8 trillion KRW by 2024.

Yoon Sung-tae, CEO of Huons Lab, stated, "Having confirmed equivalent efficacy as a biosimilar, we will proceed smoothly with follow-up studies such as non-clinical toxicity and clinical trials to swiftly launch the Prolia biosimilar."

Huons Lab is a company developing biopharmaceuticals and biosimilars and is the third company in Korea to independently develop a Prolia biosimilar.