Hospira's Inflectra Gets European Commission Approval

(RTTNews) - Provider of injectable drugs and infusion technologies Hospira (HSP) Tuesday said its biosimilar monoclonal antibody or mAb therapy, Inflectra, has been approved by the European Commission, for the treatment of inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis.

Hospira also said Inflectra is a biosimilar medicine to the reference medicinal product, Remicade, and is the first mAb to be approved through the European Medicines Agency 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 $2 billion in 2012. The introduction of biosimilar mAbs in Europe is expected to deliver savings of up to 20.4 billion euros by 2020, with the biggest savings predicted in France, Germany and the UK.