Research & Development

Sandoz has announced that it has entered into a development and commercialisation agreement with Samsung Bioepis, providing Sandoz the exclusive rights to commercialise the biosimilar SB17 ustekinumab in the US, Canada, EEA, Switzerland and the UK.

The drug’s reference medicine, Stelara, is a monoclonal antibody medication to interleukin (IL)-12/23, indicated for the treatment of autoimmune disorders such as Crohn’s disease, plaque psoriasis, psoriatic arthritis and ulcerative colitis.

Phase 1 results assessing SB17 were presented at the American Academy of Dermatology (AAD) Annual Meeting in March 2023, and demonstrated that the drug matches its reference in terms of pharmacokinetic bioequivalence, safety, tolerability and immunogenicity. Phase 3 clinical study results are expected to be shared at a medical congress later in 2023.

Richard Saynor, CEO of Sandoz, commented: “This deal represents another major step to reinforce our high-value biosimilar pipeline, in line with our plans to become a standalone global leader. It will further strengthen our immunology patient offering and means we now have five potential high-value upcoming biosimilar launches over the next few years.”

Further terms of the agreement have not been announced.