Samsung Bioepis said it has made significant progress with its autoimmune disease treatment biosimilar, SB17, suggesting its potential use across all indications treatable by the original drug, Stelara.

Stelara is an interleukin (IL)-12, 23 inhibitor developed by Janssen. It is used to treat inflammatory autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

The announcement was made in conjunction with the presentation of two new study results at the 19th Congress of the European Crohn's and Colitis Organisation (ECCO), which is currently ongoing from Wednesday to Saturday in Stockholm, Sweden.

The studies highlighted the structural, physicochemical, and biological equivalence of SB17 to Stelara, underpinning the biosimilar's potential application beyond its initial indication for moderate-to-severe plaque psoriasis.

Samsung Bioepis has completed phase 3 clinical trials involving 503 patients across eight countries, affirming SB17's comparability to the original medication in November 2022.

One of the studies provided a comprehensive analytical assessment, showing SB17's high similarity to the reference ustekinumab, which is marketed as Stelara in Europe and the U.S.

This includes a detailed evaluation of SB17's physicochemical, non-clinical, and clinical attributes, supporting the biosimilar's extrapolation to all indications of the original drug.

"The presentations we studied show our ongoing commitment to providing clinically proven biosimilars in terms of efficacy, and safety to patients who need them and making physicians and patients confident in the use of biosimilars across indications," said Kim Hye-jin, Vice President and Medical and Lifecycle Safety Team Leader at Samsung Bioepis.

Meanwhile, Samsung Bioepis has positioned SB17 as its fourth immunology pipeline candidate, announcing a strategic partnership with Sandoz in Sept. 2023 for the commercialization of SB17 in the U.S., Canada, the European Economic Area (EEA), Switzerland, and the U.K.