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.
Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.