European Experience of Infliximab Biosimilars for the Treatment of Inflammatory Bowel Disease.

PL A biosimilar is a biologic drug that has been produced to closely resemble a drug whose patent has expired. Thus, a biosimilar is very similar, but not identical, to the originator drug. As of January 14, 2016, 22 biosimilars have been approved by the European Medicines Agency. Treatment areas include diabetes (insulin; Abasaglar, Lilly), neutropenia/anemia (filgrastim; Accofil, Accord and Filgrastim Hexal, Hexal), and rheumatoid arthritis (etanercept; Benepali, Samsung). The first biosimilars for inflammatory bowel disease (IBD) in the European Union were registered in 2013, and the first use of biosimilars of infliximab (reference product Remicade, Janssen) began around the spring and summer of 2014. Currently, there are 2 infliximab biosimilars available in Europe (Remsima, Celltrion and Inflectra, Hospira). In addition, IBD biosimilars have been in use in Korea since 2012. They are not yet being used in the United States.