Report: Approval of first biosimilar MAb in Europe has major implications for 2014 and beyond

Key clinical, corporate and regulatory events affecting the biosimilar industry have been identified by health care advisory group Decision Resources, which finds that 2013 was a pivotal year for biosimilars.

The Strategic Insights report, titled Biosimilars in 2013: Landmark Events and What They Mean for 2014 and Beyond, notes the approval of the first biosimilar monoclonal antibody (MAb) in Europe - Celltrion’s Remsima and Hospira’s Inflectra, a biosimilar version of US pharma giant Merck & Co’s Remicade (infliximab) - will have major implications for 2014 and beyond. Merck markets the drug in Europe, while Johnson & Johnson does so elsewhere.

Inflectra has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis (The Pharma Letter September 10).

The report finds that, while biosimilars in other product classes (ie, human growth hormone, granulocyte colony-stimulating factors and erythropoiesis-stimulating agents) have been available in Europe for several years, overall biosimilars sales remain relatively modest. The advent of the first European biosimilar monoclonal antibody heralds a new dawn in the industry. This second wave of products is expected to bring more significant commercial rewards compared with the first wave of biosimilar products.