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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Celltrion is seeking US approval for its subcutaneous formulation of infliximab, marketed in other territories as Remsima SC. The product will be registered as a standalone biologic rather than a biosimilar.
Celltrion says new data show that its Remsima SC subcutaneous infliximab biosimilar produces “statistically greater improvements in clinical outcomes” for rheumatoid arthritis patients compared to intravenous infliximab.
Oral delivery of biosimilars could bring significant benefits for patients as well as offering a key differentiating factor for competing developers, especially in the US adalimumab arena, Rani Therapeutics CEO Talat Imran tells Generics Bulletin.