Infliximab biosimilars get the EC approval

September 12, 2013 10:16 AM

Following the EMA’s CHMP recommendation in June, the European Commission has recently approved the first infliximab biosimilars, which are referenced to Remicade.

Remsima/Inflectra which was developed by Celltrion Inc. of South Korea, has already shown to be similar to the biosimilar medicine Remicade, a monoclonal antibody that has been authorized in the EU since 1999.

Following the recent approval of European Commission, EGA, The European Generic medicines Association issued a press release and welcomed these two approvals.

“The rigorous processes established to validate biosimilarity mean that member states can be truly confident in the data supporting these medicines,” explained Victor Lino Mendonca, EGA’s Head of Pharmaceutical Policy. “The regulatory criteria established by the European Medicines Agency resulted in both products being subject to extensive testing, including phase III trials, before marketing authorisation could be granted. The robust nature of this process, and the reassuring outcome of the trials, helps to remove potential clinical obstacles to market entry.”

These approvals should encourage member states to rapidly introduce these new alternatives to the market as they will reduce inequalities in patient access to treatment while also delivering cost savings for their health services.

“The biosimilar medicines industry is bringing important therapeutic alternatives to patients and healthcare providers that constitute a powerful tool for policy makers to manage the healthcare budgets in a more cost-effective way while creating new jobs in Europe. The countdown has started and member states now have the opportunity to take full advantage of these new treatments options”, said EGA’s President Gudbjorg Edda Eggertsdottir.

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