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Two biosimilar TNF-alfa monoclonal antibody (mAb) products were approved for clinical use in the European Union on 10 September 2013, following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in July 2013. The products, with trade names Remsima and Infl ectra (INNs infl iximab) contain an identical mAb. This approval shows the feasibility of using the biosimilar pathway for mAbs and paves the way for further biosimilar mAb products.

Biosimilar monoclonal antibodies approved for use in the EU