LG Chem has received sales approval from the Ministry of Food and Drug Safety (MFDS) for Eucept, an Enbrel biosimilar (ingredient: etanercept), an autoimmune disease treatment, the company said.
Eucept is the second Enbrel biosimilar to receive regulatory approval in Korea. It comes three years after Samsung Bioepis’ Brenzys received approval in 2015.
Enbrel is one of the most purchased pharmaceuticals worldwide with an estimated $8.87 billion in sales in 2016. It has applications for autoimmune diseases, including rheumatoid arthritis, psoriasis, and other inflammatory conditions.
The company has confirmed the safety and efficacy of the drug through a local phase 3 clinical trial on 185 patients in 30 local hospitals since 2014.
Unlike other Enbrel biosimilar competitors that use self-injection methods, the company has applied an auto-injection method with slimmer needles, making the injection procedure more comfortable and less painful for patients.
The company plans to market the drug in the first half of this year after receiving insurance coverage.
”We will expand our presence in the domestic market based on differentiated competitiveness, such as our large-scale clinical trial results on Koreans,” said Son Jee-woong, head of LG Chem's Life Science Business Division. “The company aims to improve the quality of life and reduce the economic burden of patients with rheumatoid arthritis.”