EU approves Remicade biosimilar Inflectra
Hospira has announced the European Commission (EC) approval of Inflectra (infliximab), Europe's first biosimilar monoclonal antibody (mAb) therapy. Inflectra has been approved for the treatment of inflammatory conditions including Rheumatoid Arthritis (RA), Ankylosing Spondylitis, Crohn's disease (CD), Ulcerative Colitis (UC), Psoriatic Arthritis (PsA) and Psoriasis.
Inflectra is a biosimilar medicine to the reference medicinal product, Remicade (infliximab), and is the first monoclonal antibody (mAb) to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway. A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic. Remicade recorded European sales of over USD 2 billion in 2012.
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