Samsung Bioepis Demonstrates Potential for Indication Expansion of Stelara Biosimilar

Samsung Bioepis announced on the 22nd that it presented two abstracts of follow-up clinical trial research results for SB17, a biosimilar of the autoimmune disease treatment Stelara, at the European Crohn's and Colitis Organisation (ECCO) Annual Meeting held from the 21st to the 24th (local time) in Stockholm, Sweden.

Samsung Bioepis Headquarters Exterior [Photo by Samsung Bioepis]

Stelara, developed by Johnson & Johnson (J&J), is a drug used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, and Crohn's disease. It is a blockbuster drug that generated sales of $10.858 billion (approximately 14.5 trillion KRW) worldwide last year alone. Autoimmune diseases occur when the immune system mistakenly recognizes normal cells in the body as enemies rather than external threats and attacks them. During this process, interleukins, which are proteins secreted by white blood cells that activate immune cells, play a key role. Stelara treats autoimmune diseases by inhibiting the activity of interleukin-12 and interleukin-23.

Regarding SB17, Samsung Bioepis disclosed abstracts that include ▲an analysis of the structural, physicochemical, biophysical, and biological characteristics of SB17 compared to Stelara, confirming equivalence in all aspects ▲and a comprehensive evidence abstract based on physicochemical, non-clinical, and clinical equivalence with Stelara.

In particular, through the second abstract, it was emphasized that 'extrapolation' to other indications is possible. Currently, Stelara is approved in South Korea for the treatment of plaque psoriasis as well as psoriatic arthritis, Crohn's disease, and ulcerative colitis. However, biosimilars do not conduct clinical trials for all these indications during development but only for some indications. Samsung Bioepis also conducted Phase 3 clinical trials for SB17 only in patients with plaque psoriasis. Developers use a strategy called indication extrapolation, where they prove equivalence with the original drug through comprehensive evidence combining various research results beyond clinical trial outcomes and gain approval for indications other than those directly tested in clinical trials.

Kim Hye-jin, Medical Team Leader (Executive Director) at Samsung Bioepis, said, “Through the abstracts presented at this academic conference, we have once again demonstrated the equivalence between SB17 and the original drug. Based on the research results, we will strive to provide biosimilar treatment opportunities to more patients.”

This content was produced with the assistance of AI translation services.