Daewoong Pharm launches Humira biosimilar targeting autoimmune disease market
Daewoong Pharmaceutical said on Monday that it launched Xelenka, LG Chem's biosimilar referencing Humira (active ingredient: adalimumab), in Korea. Approved by the Ministry of Food and Drug Safety (MFDS) in December last year, Xelenka marks the third biosimilar of Humira introduced in Korea.
Under a distributor agreement between Daewoong Pharmaceutical and LG Chem, LG Chem will supply Xelenka to Daewoong Pharmaceutical, which will handle domestic sales and marketing. This collaboration builds on the companies' previous joint efforts, including the co-marketing and sales of the diabetes medications Zemiglo and Zemimet.
The increasing prevalence of autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis, driven by an aging population, urbanization, and lifestyle changes, underscores the demand for affordable treatments. Original biologics like Humira are often prohibitively expensive, making long-term treatment financially challenging for many patients.
In Korea, three Humira biosimilars are available -- Daewoong and LG Chem's Xelenka, Samsung Bioepis' Hadlima, and Celltrion's Yuflyma.
Daewoong Pharmaceutical argued Xelenka is positioned as the "most cost-effective" biosimilar of Humira in Korea. It is priced at 220,390 won ($160) for the 40 mg dose and is covered by insurance. This pricing strategy aims to "enhance patient accessibility to timely treatment while also reducing health insurance costs," a Daewoong Pharmaceutical spokesperson said.
Xelenka is available in two formulations: a pre-filled syringe and an autoinjector. The autoinjector, designed by LG Chem, enhances ease of use by allowing automatic administration with slight pressure, accompanied by an audible confirmation click before and after injection.
The domestic development, clinical studies, approval, and production of Xelenka offer advantages in quality control and cost efficiency. Local production facilitates quick resolution of production issues and minimizes stability concerns by ensuring strict temperature and storage management during distribution. Joint clinical development in Korea and Japan has also provided domestic doctors with valuable experience in using the product, said Daewoong Pharmaceutical.
Xelenka, in clinical trials conducted by LG Chem, has shown comparable efficacy and safety to Humira in treating active rheumatoid arthritis. A 52-week phase 3 trial across Korea and Japan with 383 patients demonstrated equivalent efficacy in reducing DAS28-ESR scores by week 24, matching Humira's performance.
Safety profiles were similar, with adverse event rates at 68.2 percent for Xelenka and 71.2 percent for Humira by week 24 and consistent throughout the study period. Efficacy and safety remained consistent for patients who switched from Humira to Xelenka after 24 weeks.
Xelenka is approved for all indications of Humira, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, Crohn's disease, ulcerative colitis, Behçet's enteritis, uveitis, hidradenitis suppurativa, and juvenile idiopathic arthritis.
Looking ahead, Daewoong Pharmaceutical plans to expand its biopharmaceutical pipeline, aiming to significantly improve the treatment of various diseases and the quality of life.
"We are pleased that the launch of Xelenka will help ease the burden of medical expenses for the country and patients and provide a reasonable choice in the medical field,” said Lee Chang-jae, CEO of Daewoong Pharmaceutical. “Xelenka is expected to bring new changes to the domestic biosimilar market and provide new options for both patients and healthcare providers.”