BRUSSELS, 1 July 2013 – The EGA welcomes the European Medicines Agency’s recommendation to the European Commission to approve the first two infliximab biosimilar products, both referenced to Remicade©. “This is a key milestone in the history of medicines in the EU, firstly for the patients who suffer from auto-immune illnesses and secondly for the EU healthcare systems because biosimilar medicines provide real opportunities to reduce the cost of treatment with biopharmaceuticals without compromising the quality of healthcare that is delivered. Biosimilar medicines will also contribute to making these treatments available to more patients” commented Beata Stepniewska, EGA Acting Director General.
As highlighted by the European Medicines Agency, this is the first time that the biosimilar concept has been successfully applied to a complex molecule such as infliximab. “These positive scientific opinions of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) further confirm that science and technology are in place to develop biosimilar products of structurally complex substances such as monoclonal antibodies and that they can be authorised in the same indications as their reference product” added Suzette Kox, EGA Senior Director Scientific Affairs.
A new era of biosimilar medicines is about to start. “To realise the economic benefits of biosimilar medicines’ adoption, policy makers, payors, prescribers and manufacturers must work together to establish sustainable market access mechanisms” said EGA’s President Gudbjorg Edda Eggertsdottir.
FURTHER INFORMATION, SUZETTE KOX