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 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.
Celltrion says it is ready to roll out its Remsima SC subcutaneous infliximab in Europe in the first quarter of 2020, after receiving a formal pan-European marketing authorization from the European Commission.
Teva and Celltrion have launched the first biosimilar rituximab in the US, introducing Truxima at a 10% discount to Roche’s Rituxan.