Tuesday, October 22, 2019
Ready for Sale in Europe
Celltrion’s Remsima
Ready for Sale in Europe
  • By matthew
  • August 29, 2013, 05:32
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Remsima is infliximab, a monoclonal antibody that binds to and blocks TNF-alpha, a pro-inflammatory factor released during autoimmune diseases.
Remsima is infliximab, a monoclonal antibody that binds to and blocks TNF-alpha, a pro-inflammatory factor released during autoimmune diseases.

 

Celltrion announced on August 28 that the European Commission accepted the opinion of the European Medicines Agency (EMA) and gave final approval for the sale of Remsima, which is the world’s first antibody biosimilar developed by Celltrion. 

Down the road, the new drug will be able to be sold in 28 EU member countries, and three more in the European Economic Area (EEA). Celltrion is planning to start the sale from those countries where there is no original drug patent or such patents have expired. 

The final approval has been made after the EMA looked into the scientific and technical aspects of the medicine, including the summary of product characteristics (SmPC), product guides translated into 20 languages spoken in the region, side effect reporting systems and the like, to determine whether the company is ready to sale the medicine in Europe.