Korea's Ministry of Food and Drug Safety granted marketing approval to the biosimilar on March 17, to be sold as Eucept.
Korean media are reporting that LG Chem has obtained regulatory approval to begin marketing its etanercept biosimilar in the Republic of Korea. According to The Investor, the Ministry of Food and Drug Safety granted marketing approval to the biosimilar, which will be sold as Eucept, on March 17. Eucept—also approved for marketing by Japan’s Ministry of Health, Labor and Welfare—is LG Chem’s first biosimilar.
LG Chem’s product seeks to differentiate itself from its reference drug, Enbrel, and Samsung Bioepis’ biosimilar etanercept, Brenzys, with its innovative device design. The drug is provided in an autoinjector device that uses thin needles, making self-administration easier and less painful for patients.
A recent study evaluating the biosimilar in comparison with its reference found that Eucept had equivalent clinical efficacy and a comparable safety profile to the reference etanercept, and was well tolerated. The phase 3 study, conducted in patients with rheumatoid arthritis at 48 centers in Japan and 30 centers in the Republic of Korea, also found that injection-site reactions occurred in fewer patients receiving the biosimilar than patients receiving the reference drug.
The researchers cautioned that, because the study was only conducted in Asian nations, the findings related to injection-site reactions may be limited to Asian patients. Therefore, further studies will be warranted for the drug’s use in other populations. An additional 48-week period following the initial 52-week treatment period is currently underway, and will provide long-term safety, efficacy, and immunogenicity data for the biosimilar.
In the Korean marketplace, the study’s findings concerning injection site reactions may provide LG Chem’s product with a competitive edge; Jee Woong Son, head of LG Chem’s life science business division, told Korea Biomedical Review that “We will expand our presence in the domestic market based on differentiated competitiveness, such as our large-scale clinical trial results on Koreans.”
In addition to Eucept, LG Chem is also developing an adalimumab biosimilar, LBAL, referencing Humira. According to its website, the company is in phase 3 development with the adalimumab candidate. The company is also developing novel drugs targeting inflammatory diseases, type 2 diabetes, cancer, and myocardial infarction.