LG Life Sciences on Tuesday said that it has begun phase III clinical trials for its new Humira biosimilar under development in South Korea, with plans to commercialize the drug in Korea and Japan by 2018.
The Korean Ministry of Food and Drug Safety approved the final-stage clinical trials for LBAL, LG’s Humira biosimilar on May 27, prompting the company to begin its trials, said company spokesman Park Jun-hyoung.
Developed by U.S. pharmaceutical giant AbbVie, Humira (adalimumab) is the world’s top-selling drug, having generated sales of $14 billion last year.
Its formulation patent is scheduled to expire around the world starting from 2018, making way for the introduction of biosimilars, which refer to near replicas of biologic drugs which have lost patent protection.
The ongoing trials will test the effectiveness of LBAL on rheumatoid arthritis patients who have shown negative responses to methotrexate, a chemotherapy drug, as well as the comparative effects and safety of Humira and LBAL among local patients.
LG Life Sciences declined to comment on the size and details of its ongoing trials, citing corporate compliance rules.
The firm is expecting to commercialize LBAL in Korea by 2018, Park said. In Japan, LG’s licensing partner Mochida Pharmaceutical is preparing to commercialize LG’s Humira biosimilar by then as well.
Meanwhile, LG Life Sciences is preparing to launch a new biosimilar referencing Enbrel (etanercept) in Korea and Japan by 2018. The biosimilar drug is currently undergoing phase III trials in both countries.
By Sohn Ji-young (jys@heraldcorp.com)