Latest From Celltrion Inc.
Mylan and Biocon have launched their Ogivri trastuzumab biosimilar in the US, marking the second biosimilar rival to Herceptin and leading a new wave of trastuzumab biosimilars expected to arrive in the US early next year.
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.
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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