LG Chem obtains approval for Humira biosimilar in Korea

[Courtesy of LG Chem]

LG Chem Ltd. announced Friday that it has received authorization from South Korea’s Ministry of Food and Drug Safety for its biosimilar LBAL, developed as an alternative to the autoimmune disease treatment, adalimumab, sold under the brand name Humira.

The company had filed for marketing approval with the ministry in December 2022, securing authorization within just about a year.

LBAL serves as a biosimilar product developed as a high-concentration formulation of Humira, designed to enhance patient convenience by removing citrate, which can cause discomfort for patients, the company said.

The approval will offer patients dealing with autoimmune diseases more treatment choices, alongside the company’s previously released etanercept biosimilar Eucept.

Humira, developed by the multinational pharmaceutical company AbbVie in the U.S. is a blockbuster medication used to address conditions like rheumatoid arthritis, ankylosing spondylitis, psoriasis, and more.

Adalimumab functions as a human monoclonal antibody, effectively inhibiting tumor necrosis factor (TNF), a soluble inflammatory cytokine responsible for inflammatory reactions in autoimmune diseases.

Other Korean companies licensed to sell their own biosimilars of Humira include Samsung Bioepis Co. and Celltrion Inc.