[THE INVESTOR] LG Chem, Korea’s leading chemicals maker under LG Group, has obtained regulatory approval to begin marketing and selling its Enbrel biosimilar in Korea.
Korea’s Ministry of Food and Drug Safety on March 17 granted marketing approval for LG Chem’s Eucept, a cheaper biosimilar copy of Amgen’s blockbuster arthritis drug Enbrel (etanercept).
Biosimilars refer to cheaper, near-replicas of living biologic drugs made from living cells through highly complex engineering processes, whose patents have expired.
LG Chem’s Eucept is the first monoclonal antibody drug developed by the company. It has been approved for the treatment of conditions including rheumatoid arthritis, axial spondyloarthritis and psoriasis.
Eucept is the second Enbrel biosimilar to be launched in Korea. It comes three years after Samsung Bioepis’ Enbrel biosimilar, sold under the name Brenzys, which was approved in Korea in 2015.
Nonetheless, LG Chem wants to take an aim at the local etanercept market estimated at 30 billion won (US$28.08 million) with two competitive points -- clinical data catered to local patients and drug administration convenience.
LG plans to highlight the drug’s reliability and safety based on phase-three clinical trial data for Eucept it has collected from 185 patients in 30 local hospitals from 2014.
It is also betting on the Eucept’s convenient design to win over local patients. Unlike competitors, Eucept has been made in an autoinjector type with slimmer needles, making the injection procedure easier and less painful for patients who have to self-inject the drugs regularly.
LG Chem’s new drug development activities are led by the company’s biopharmaceutical unit, previously known as LG Life Sciences. The two firms merged in January 2017.
By Sohn Ji-young/The Korea Herald (email@example.com)