Sandoz to Market Samsung Bioepis’ Ustekinumab Biosimilar

Samsung Bioepis announced this week that it had signed a commercialization agreement with Sandoz regarding their investigational biosimilar ustekinumab candidate SB17. This is Samsung Bioepis’ first marketing agreement with Sandoz; the company has marketing agreements in place with Organon for  Renflexis® (infliximab), Hadlima® (adalimumab), and Ontruzant® (trastuzumab); and with Biogen for Byooviz®.

In response to our question as to whether this agreement may signal a more extensive partnership with Sandoz, a spokesperson from Samsung Bioepis Emailed the following statement: “We have always sought, and will seek the most optimal option that allows access to our biosimilars for patients who are in need of medicines, and while it has been through commercial partnerships for most of our products, it does not mean that we will always be considering commercial partnerships for future products or for other regions which do not fall under commercial partnerships. Our long-term goal has been, and will always be, to become a fully integrated global pharmaceutical company with end-to-end capabilities from pre-clinical development to commercialization.”

Even though Samsung Bioepis harbors hopes of one day marketing their own products, the agreement seems to be a particularly good fit for Sandoz: It is one of the few major biosimilar manufacturers that did not already have a Stelara® biosimilar under development. Under the terms of the arrangement, Sandoz will have commercialization rights for the product, once approved, in Europe and North America.

The phase 3 clinical trial for SB17 was completed in 2022, and a 351(k) filing may be expected in the near future, allowing Samsung to join Celltrion, Alvotech, and perhaps Formycon in the first wave of ustekinumab biosimilar applications. There may be as many as eight biosimilar competitors for this agent.

Sandoz has been quite active in the headlines recently, with the announcement as supplier of an adalimumab biosimilar to CVS Health’s Cordavis, the FDA approval of Tyruko® for the treatment of multiple sclerosis and Crohn’s disease, and its anticipated spin-off from Novartis, which is to occur “on or around October 4, 2023.”

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