Fri, Sep 13, 2013 10:57 AM
Marketing authorisation for biosimilar infliximab in EU
Egis is first to launch biosimilar monoclonal antibody within the European Union.

Egis is first to launch biosimilar monoclonal antibody within the European Union

Egis Pharmaceuticals PLC announces that, the European Commission has approved the
marketing authorization of Remsima™ containing the active ingredient infliximab for the
indications of its reference originator product, Remicade® such as rheumatoid arthritis,
pediatric and adolescent Crohn disease, pediatric and adolescent colitis ulcerosa, spondylitis
ankylopoetica, arthritis psoriatica, psoriasis.

This is a milestone for European healthcare, as Remsima™ is the first biosimilar monoclonal
antibody (mAb) to receive approval from the European Commission based on the European
Medicines Agency’s opinion. With its launch, Egis pioneers the biosimilar mAb therapies,
providing patients wider access to advanced, affordable and more cost-effective treatment of
autoimmune diseases in Central Eastern Europe.

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