Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)

Shots: The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors Novolumab is an mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I…

ByDipanshu DixitDecember 19, 2025

Key Biosimilars Events of April 2025

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   Henlius Collaborates with Sandoz for the Commercialization of HLX13. Our team at PharmaShots…

ByDipanshu DixitMay 6, 2025

Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy)

Shots: Henlius has granted Sandoz exclusive rights of the HLX13, a biosimilar version of Yervoy (ipilimumab), which is being assessed in a Henlius-led P-I/III trial for inoperable HCC, targeting enrollment of 656 pts As per the deal, Sandoz will register & market HLX13 in Australia, Canada, EU, Japan, & the US in exchange for milestone-based…

ByRidhi RastogiApril 30, 2025

Shanghai Henlius Receives the US FDA IND Clearance for HLX18 (Biosimilar, Opdivo)

Key Biosimilars Events of April 2025

Henlius and Sandoz Enter a Global Collaboration Agreement to Commercialize HLX13 (Biosimilar, Yervoy)

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