Novartis’ Generic-drugs Unit Partners with Samsung Bioepis for Biosimilar Drug Launch

In a strategic move aimed at expanding its footprint in the biosimilars market, Sandoz, Novartis’ generic-drugs unit, has announced its plans to launch a generic version of Johnson & Johnson’s anti-inflammatory drug, Stelara. This endeavor is the result of a collaboration deal between Sandoz and Samsung Bioepis.

Sandoz, a leading global provider of generic and biosimilar medicines, has entered into a development and commercialization agreement with Samsung Bioepis. This agreement grants Sandoz exclusive rights to commercialize the biosimilar SB17 ustekinumab in several regions, including the United States, Canada, EEA, Switzerland, and the UK..

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Collaboration Aims at Introducing Biosimilar Version of Johnson & Johnson’s Stelara

Stelara (ustekinumab) is a monoclonal antibody medication developed by Janssen Pharmaceuticals used to treat autoimmune disorders such as Crohn’s disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis. The U.S. patent for Stelara will expire in 2023, while the European Union’s is set to expire in January, 2024, therefore Sandoz aims to create a biosimilar of Stelara, which would offer a lower-cost alternative to patients.

The biosimilars market has been growing steadily, offering more affordable options for complex biotech drugs that have lost their patent protection. Sandoz’s collaboration with Samsung Bioepis strengthens its position in this expanding market.

Under this partnership, Sandoz has secured exclusive rights to commercialize the biosimilar product in the United States, Canada, and most of Europe. The clinical development program for the Stelara biosimilar is in an advanced stage, and Sandoz is confident about its potential success in the market.

Sandoz CEO Richard Saynor expressed enthusiasm for this collaboration, emphasizing that it would fortify their immunology patient offering and contribute to their growing biosimilar portfolio. Sandoz now anticipates launching five high-value biosimilars in the coming years.

Sandoz Reinforces Biosimilar Pipeline and Immunology Offerings with Samsung Bioepis Agreement

While Sandoz is poised to make substantial investments in biosimilars, the move also comes at a significant juncture for the company as it prepares to become an independent entity. The spin-off from Novartis is scheduled for early October, with shareholders set to vote on the matter on September 15.

The clinical development program for SB17, a biosimilar of Stelara, has progressed significantly. Phase I results, which demonstrated bioequivalence, safety, tolerability, and immunogenicity comparable to the reference Stelara, were presented at the American Academy of Dermatology (AAD) Annual Meeting in March 2023. Phase III results are expected to be presented at a medical congress later this year.

Sandoz’s commitment to biosimilars reflects a broader industry trend aimed at offering more accessible and cost-effective alternatives to complex biotech drugs. This partnership with Samsung Bioepis aligns with Sandoz’s mission to enhance patient care and expand its presence in the biosimilars market.

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Author

Sinead Huang