Shots:

• Samsung Bioepis has successfully resolved all patent litigation with Johnson & Johnson through a settlement & license agreement. This significant development clears the legal obstacles for the US commercialization of SB17 (biosimilar ustekinumab)
• The license period is set to commence on Feb 22, 2025, with specific terms remaining confidential. SB17 serves as an alternative for plaque psoriasis, CD, UC, & active PsA – indications for which Stelara is approved
• The BLA for SB17 is currently under review by the US FDA. Upon approval, SB17 will be commercialized in the US by Sandoz, as outlined in the development & commercialization agreement between Samsung Bioepis & Sandoz, signed in Sep 2023. This collaboration extends to the markets of the US, Canada, EEA, Switzerland, and UK

Ref: Samsung Bioepis | Image: Samsung Bioepis

Related News:- Sandoz Entered into a Development and Commercialization Agreement with Samsung Bioepis for SB17, a Proposed Biosimilar to Stelara

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