Hospira wins approval for Europe's first biosimilar monoclonal antibody

LEAMINGTON SPA, United Kingdom — European regulators have approved the European Union's first biosimilar monoclonal antibody. The new product, made by U.S.-based Hospira, comes seven years after the approval of Europe's first biosimilar.

Hospira announced Tuesday the European Medicines Agency's approval of Inflectra (infliximab) for the treatment of autoimmune disorders like rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis.

The product is a biosimilar version of Merck's and Johnson & Johnson's Remicade, which had sales in Europe of $2 billion last year, according to Merck. Merck and J&J agreed to split sales of the drug in 2011 as part of a settlement in a lawsuit. According to a study published last year in the Generics and Biosimilars Initiative Journal, the introduction of biosimilar monoclonal antibodies in Europe is expected to deliver savings of more than $27 billion by 2020, particularly in France, Germany and the United Kingdom.

"The rigorous scientific review and approval process by the EMA and [European Commission] confirms that Inflectra has demonstrated similar quality, efficacy and safety to Remicade," Hospira corporate VP and chief medical officer Stan Bukofzer said. "For more than a decade, biologic medicines have been pivotal in treating a range of inflammatory conditions, so the granting of marketing authorization in Europe is a major milestone for Inflectra and for the future of biologic therapy."

The growth disorder treatment Omnitrope (somatropin [rDNA origin]), made by Novartis generics division Sandoz, was the first biosimilar to win approval in Europe, in 2006. The drug, which is a version of Pfizer's Genotropin, was also approved by the U.S. Food and Drug Administration the same year as a special consideration. However, it was only with the approval of amendments to the Patient Protection and Affordable Care Act in 2010 that the United States got its own abbreviated approval pathway for biosimilars, and the FDA is still working on regulations.