April 25, 2024

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[THE INVESTOR] LG Chem is expected to commercialize its first copycat version of a pricey biologic drug early 2018 in Korea and Japan, jumping on the biosimilar bandwagon, the company said on July 12.

The company has applied to Japan’s Health Ministry for approval of its biosimilar candidate LBEC0101 referencing Amgen’s blockbuster rheumatoid arthritis drug Enbrel. It expects to clear the final regulatory hurdle by the end of this year. 

LG Chem CEO Park Jin-soo

“Starting with the Enbrel biosimilar in 2018, we hope to gain global competitiveness in the biosimilar markets of Japan and Korea,” an LG Chem official told The Investor.

In 2016, Enbrel was the world’s third-best selling drug with sales of US$8.87 billion. Corresponding figures in Japan and Korea stood at some 600 billion won (US$523.78 million) and 18 billion won, respectively. A successful launch will make LG Chem the third Korean biotech company to market self-developed biosimilars competing with dozens of biologics that will lose patent protection following Celltrion and Samsung Bioepis.

The company picked Japan and Korea to launch LBEC0101 as other Enbrel biosimilar products are already selling in bigger pharma markets like the US and Europe, the official said. “We don’t have launch plans for the US and Europe, and instead will focus on Japan which is the second-largest market after Europe in terms of Enbrel sales.”

In Japan, LBEC0101 is currently the only Enbrel copycat seeking government approval after the original drug’s patent expired in 2014. Under a contract LG Chem signed with Tokyo-based Mochida Pharmaceutical in 2012, the latter holds exclusive rights for the development and sale of the biosimilars supplied by LG. The Korean firm is also pushing to further develop LBAL, a biosimilar of AbbVie’s flagship rheumatoid arthritis drug Humira undergoing phase 3 clinical trials in Japan.

In April, LG Chem CEO Park Jin-soo said the company will invest 130billion won in research and development of life science business to develop more cash cow products, vaccines and biosimilars. The firm completed its acquisition of pharmaceutical affiliate LG Life Sciences for about 1.1 trillion won to make its bio business a new growth engine in January.

By Park Han-na (hnpark@heraldcorp.com)