The forthcoming European approval of Hospira Inc./Celltrion Inc.’s biosimilar infliximab – a copy of rheumatoid arthritis drug Remicade – is an important date on the biosimilars calendar. Assuming, as most do, that the European Medicines Agency (EMA) will give it the nod, the drug – which Celltrion will co-market in the EU 27 as Remsima and Hospira will sell as Inflectra – will be the first biosimilar mAb to reach Europe, or any Western developed market. The first of a wave of complex biosimilars, mostly monoclonal antibodies, it could generate far more exciting returns than seen for first-generation copycat biologics such as erythropoietin (EPO) or filgrastim.
The case in favor of biosimilars looks even more compelling in the midst of the deepest and longest economic recession...