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

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

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  • Under the terms of the agreement, Sandoz gets an exclusive right to commercialize SB17, a proposed biosimilar to Stelara (ustekinumab) in the US, Canada, EEA, Switzerland, and UK. Stelara, a fully human mAb to interleukin (IL)-12/23 was approved for the treatment of autoimmune diseases i.e., PsO, PsA, CD, and UC
  • The agreement strengthens Sandoz's position in immunology and supports further pipeline expansion. The substance patents were set to expire in Sept 2023 in the US and July 2024 in the EU
  • The P-I clinical study of SB17 presented at AAD 2023 showed PK equivalence and comparable safety, tolerability, immunogenicity profiles b/w SB17 and reference ustekinumab

Ref: Sandoz | Image: Sandoz

Related News:- Samsung Bioepis Reports P-I Study Results of SB17, a Proposed Biosimilar to Stelara

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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