Sandoz to commercialise mAb biosimilar candidate

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Samsung Bioepis Co., Ltd. has entered into an agreement with Sandoz to commercialise SB17, a proposed biosimilar to Janssen Pharmaceuticals’ Stelara (ustekinumab).

The reference medicine Stelara (ustekinumab) is a monoclonal antibody (mAb) treatment to interleukin (IL)-12/23 indicated for autoimmune disorders including Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

About the biosimilar development deal

This agreement will help to expand access to biosimilar medicines, according to Samsung Bioepis.

Through the deal, Sandoz will have rights to commercialise the drug in US, Canada, EEA, Switzerland, and UK. Samsung Bioepis will be responsible for development, regulatory registration, manufacturing and the supply of the Stelara (ustekinumab) biosimilar.

“[It] represents another major step to reinforce our biosimilar pipeline. As a result, we now have five potential high-value biosimilars expected to launch from our global pipeline of over 25 assets over the next two years,” stated Sandoz CEO Richard Saynor.

Clinical evidence for SB17

Phase I results presented by Samsung Bioepis at the American Academy of Dermatology (AAD) Annual Meeting, in March 2023 demonstrated that SB17 matches the pharmacokinetic (PK) bioequivalence, safety, tolerability, and immunogenicity of ustekinumab. Results from a Phase III clinical study for SB17 completed in December 2022 are set to be presented at a medical congress later in 2023.

Adalimumab biosimilars shaping market, research states

Last month, Sandoz announced it was going to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.

In July 2023, Sandoz revealed that to support future development of its biosimilar pipeline, it planned to invest approximately $90 million at its site in Ljubljana, Slovenia. This move would help to establish its Sandoz Biopharma Development Center by 2026, the company stated when the news was announced.

Additionally, the company made the largest-ever international private-sector investment in Slovenia in March 2023. A total of $400 million was reported to finance a new biologics manufacturing plant in Lendava, Slovenia.