EMA's CHMP backs approval of first two monoclonal antibody biosimilars of blockbuster Remicade

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars: Inflectra from US firm Hospira (NYSE: HSP) and Remsima from South Korea’s Celltrion.

Both of these biosimilars contain the same known active substance, infliximab, marketed as Remicade by Merck & Co in Europe, where the drug - with annual sales of some $6 billion - is set to come off patent in Europe as soon as next year (and by Johnson & Johnson in the USA and other markets).

In the application dossiers, the products have been shown to be similar to the biological Remicade, a monoclonal antibody that has been authorized in the European Union since 1999. Remsima and Inflectra are recommended for authorization in the same indications as Remicade, covering a range of autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.