Samsung Bioepis, Sandoz enter commercial agreement for Stelara biosimilar

Key takeaways:

• Phase 1 pharmacokinetics results showed comparability between SB17 and ustekinumab.
• Phase 3 results of SB17 will be presented at a medical congress this year.

Samsung Bioepis Co. Ltd. announced in a press release that the company has entered a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Stelara.

The release reports that the addition of SB17 to Samsung Bioepis’ immunology portfolio will strengthen the reach of the company in the United States, Canada, European Economic Area, Switzerland and United Kingdom.

“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,” Sang-Jin Pak, MD, MSc, executive vice president and head of commercial division at Samsung Bioepis, said in the release.

SB17 is the company’s fourth biosimilar following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab).

Results from a phase 1 clinical study of SB17 that were presented at the 2023 American Academy of Dermatology Annual Meeting showed pharmacokinetics equivalence between the drug candidate and Stelara (ustekinumab), as well as similar safety, tolerability and immunogenicity profiles.

A phase 3 study evaluating SB17 was completed in December 2022 and is set to be presented at a medical congress this year, according to the release.