Another Arthritis Blockbuster Drug Faces Generic Competition: Novartis' Sandoz Inks Pact With Samsung Bioepis

Sandoz, a generic and biosimilar medicines unit of Novartis AG NVS, has entered a development and commercialization agreement with Samsung Bioepis.

The agreement provides Sandoz exclusive rights to commercialize the biosimilar SB17 ustekinumab in the US, Canada, EEA, Switzerland, and the U.K. Other specific terms of the agreement are confidential.

"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," says Sandoz CEO Richard Saynor. 

The reference medicine Johnson & Johnson JNJ Stelara (ustekinumab) is a monoclonal antibody medication to interleukin (IL)-12/23 for autoimmune disorders including Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

In 2022, Stelara generated $9.7 billion in sales.

Samsung Bioepis presented Phase 1 data for SB17, a ustekinumab biosimilar, in March 2023.

This study demonstrated that SB17 matches reference ustekinumab regarding pharmacokinetic bioequivalence, safety, tolerability, and immunogenicity.

SB17 Phase 3 study results will be presented at a medical congress later this year.

Last month, CVS Health CVS launched Cordavis, a wholly-owned subsidiary, to work directly with manufacturers to commercialize and/or co-produce biosimilar products in the U.S. pharmaceutical market.

Cordavis has contracted with Sandoz to commercialize and bring Hyrimoz (adalimumab-adaz), a biosimilar for AbbVie Inc's ABBV flagship product Humira, under its private label. 

In May, Johnson & Johnson settled its lawsuit against Amgen Inc AMGN over a proposed ustekinumab biosimilar.

Amgen said that the results would delay the anticipated launch date of the biosimilar pending FDA approval from later 2023 to "no later than January 1, 2025."