Sorrento And Mabpharm Get ‘Biobetter’ Infliximab Approval In China
Plans To File Biosimilar With Improved Safety Profile In US And Europe This Year
Sorrento and Mabpharm have revealed plans to take their infliximab “biobetter” global, after China’s NMPA approved the product, which has an improved safety profile compared to Remicade.
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Banking on the burgeoning biosimilars approvals in China, Sorrento’s partner Mabpharm has filed in China for an infliximab biosimilar. Sorrento plans to follow this up with a US filing for a ‘biobetter’ version via the BLA route in 2020.
Celltrion head of clinical development Sang Joon Lee has set out the promise of ‘biobetters’ – biosimilars that improve upon the original reference product – at the FT Global Pharmaceutical and Biotechnology Conference 2019. However, obstacles remain, including the lack of a tailored regulatory pathway.
Clear progress is being made in the European value added medicines sector, Medicines for Europe’s outgoing sector chair Arun Narayan has highlighted in an interview with Generics Bulletin. However, there is still more work to be done to ensure that the market is supported by imminent legislative and regulatory initiatives.