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Celltrion Pushes ‘Biobetters’ Concept With Remsima SC

Subcutaneous Biosimilar Infliximab Delivers On The Promise Of Biobetters

 
• By Dave Wallace

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.

Abdomen_Injection
Celltrion says its subcutaneous formulation of infliximab makes the biosimilar better than the Remicade original • Source: Shutterstock

As Celltrion prepares to receive a formal pan-European approval for its innovative subcutaneous formulation of biosimilar infliximab, the firm’s senior executive vice-president and head of clinical development, Sang Joon Lee, has set out the company’s commitment to ‘biobetters’.

The subcutaneous version of Celltrion’s Remsima biosimilar to Janssen’s Remicade received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in mid-September, meaning that the European Commission’s final approval is now expected within days

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