Samsung Bioepis, J&J Ink Settlement and License Agreement for Stelara Biosimilar

30 Nov 2023
Drug ApprovalLicense out/inAcquisitionPatent Infringement
Pictured: Businessmen shaking hands after closing a deal/iStock, AmnajKhetsamtip Samsung Bioepis has inked a settlement and license agreement with Johnson & Johnson, which will settle all U.S. patent litigation and allow for the commercialization of a biosimilar for the arthritis drug Stelara, known as SB17. According to Thursday’s announcement, Samsung Bioepis’ license period for its Stelara biosimilar will kick in on February 22, 2025. However, all the other terms of the deal were labeled as confidential and no further details were revealed. The BLA for the SB17 drug is under review by the FDA. If the drug is approved, it will be commercialized by Sandoz.   The issues between J&J and Samsung Bioepis come from the South Korean biotech filing a petition for an Inter Partes Review of J&J’s Stelara, or ustekinumab patent. According to a legal intelligence website lexology, Samsung Bioepis stated that the claims of J&J’s patent were invalid.  Patent protections over the use of one of the molecules in Stelara ended in September. “We welcome this agreement which clears the way for SB17 in the U.S., which has a potential to broaden access to treatment for patients suffering inflammatory conditions,” Kris Soyoung Lee, vice president and commercial team leader at Samsung Bioepis, said in a statement. “Through our continuous innovations in product development and an uncompromising commitment to quality, we remain dedicated to advancing and expanding our biosimilar portfolio, so that more patients and healthcare systems across the world may benefit from biosimilars.”  Samsung Bioepis and Sandoz agreed for the Novartis spinoff to commercialize the biosimilar in September 2023, with plans for commercializing the drug in Canada, Switzerland, the U.K. and the European Economic Area. Samsung and Sandoz plan to increase their efforts to commercialize biosimilars. This includes a biosimilar for Amgen’s osteoporosis drug Prolia and one for the popular eye drug Eylea.  However, Samsung and Sandoz are facing competition regarding biosimilars for Stelara. In early November, the FDA approved Wezlana as an interchangeable biosimilar to Stelara and will treat several inflammatory diseases.  The deal between Samsung and J&J comes as the Department of Health and Human Services suggested in a court document recently that Stelara may soon be “deselected” from the Inflation Reduction Act’s Drug Price Negotiation Program. Tyler Patchen is a staff writer at BioSpace. You can reach him at Follow him on LinkedIn.
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