SB17, a proposed biosimilar to Stelara (Ustekinumab), is Samsung Bioepis’ fourth candidate in the immunology pipeline, after SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab)
Sandoz is Novartis' generic-drugs unit. (Credit: Novartis AG)
Samsung Bioepis has signed a development and commercialisation agreement with Novartis’ generic-drugs unit Sandoz to commercialise SB17, a proposed biosimilar to Stelara (Ustekinumab), in Europe and North America.
Johnson & Johnson’s anti-inflammatory drug Stelara is a fully human monoclonal antibody to interleukin (IL)-12/23. It is authorised to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Under the partnership, Sandoz will own the exclusive rights to commercialise the SB17 in the US, Canada, EEA, Switzerland, and the UK.
The deal is expected to support the expansion of Samsung Bioepis’ pipeline and provide enhanced access to biosimilars. SB17 is the fourth candidate in the immunology pipeline of the wholly-owned subsidiary of Samsung Biologics.
Sandoz CEO Richard Saynor said: “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.”
The clinical development programme for SB17 is well progressed and Phase 1 results were announced in March 2023 by Samsung Bioepis.
This study showed that, in terms of pharmacokinetic (PK) bioequivalence, safety, tolerability, and immunogenicity, SB17 is comparable to reference Ustekinumab.
Samsung Bioepis Commercial Division head and executive vice president Sang-Jin Pak said: “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.”
In a separate development, Novartis announced a voluntary nationwide recall of one lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US at the consumer level.
Sandimmune Oral Solution, packaged in 50mL bottles, is intended for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
Novartis is recalling the solution due to crystal formation observed in some bottles, which could potentially result in incorrect dosing.