Celltrion Pushes ‘Biobetters’ Concept With Remsima SC
Subcutaneous Biosimilar Infliximab Delivers On The Promise Of Biobetters
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.
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As Celltrion Healthcare prepares to roll out Remsima SC, its subcutaneous infliximab, in Europe – starting in the UK and Germany – Celltrion Healthcare’s UK commercial head, Matthew Eddleston, speaks to Generics Bulletin about how the innovative biosimilar will be positioned in the market.
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 plans to launch its new subcutaneous formulation of Remsima in Europe next year beginning with Germany and then to get approvals for all indications by mid-2020. It has indicated that prices will be higher than first-line anti-TNF treatments but competitive with second-line rheumatoid arthritis treatments, as it pursues a strategy to gain substantial market share.