First biosimilar monoclonal antibody approved in Europe

US injectables and infusion technologies firm Hospira (NYSE: HSP) says the European Commission has approved its Inflectra (infliximab), making it Europe's first biosimilar monoclonal antibody (MAb) therapy.

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. Infliximab is the active ingredient of blockbuster drug Remicade, marketed in Europe by Merck & Co’s (NYSE: MRK) and generated sales of $2 billion in Europe, where it is set to come off patent as soon as next year. The drug, with total annual sales of around $6 billion, is commercialized outside Europe by Johnson & Johnson (NYSE: JNJ).

"The rigorous scientific review and approval process by the EMA [European Medicines Agency] and EC confirms that Inflectra has demonstrated similar quality, efficacy and safety to Remicade. For over 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," said Stan Bukofzer, corporate vice president and chief medical officer at Hospira.