Samsung Bioepis said it has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar for Stelara (ingredient: ustekinumab), for North America and Europe.

Stelara was developed by multinational pharmaceutical company Janssen, the pharmaceutical arm of Johnson & Johnson (J&J), and is used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

The substance patents were set to expire in September this year in the U.S. and July 2024 in Europe.

In July, Samsung Bioepis completed a U.S. patent settlement with J&J for SB17. However, the two companies agreed not to disclose the timing of the launch.

As Samsung Bioepis had completed clinical trials for SB17, it only has the approval application process left before launching the biosimilar. 

"This agreement is a testament to Samsung Bioepis' strong track record in the field of immunology, demonstrating a potential value that our biosimilars could deliver for widening access to biologic medicines," said Pak Sang-jin, Executive Vice President and Head of Commercial Division at Samsung Bioepis.

Meanwhile, SB17 is Samsung Bioepis' fourth candidate in the immunology pipeline, following SB4 (etanercept), SB2 (infliximab), and SB5 (adalimumab).

In March, the company presented phase 1 clinical study results of SB17 at the 2023 American Academy of Dermatology (AAD) Annual Meeting, which demonstrated pharmacokinetics (PK) equivalence and comparable safety, tolerability, immunogenicity profiles between SB17 and Stelara. SB17's phase 3 clinical study results are set to be presented at a medical congress this year as the company completed the study in December 2022.

According to IQVIA, a drug market research firm, the global market for ustekinumab was $17.7 billion in 2022.