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.