First biosimilar mAb approved in Europe

Hospira's Inflectra (infliximab), which is a biosimilar to the reference biologic product, Remicade, has been approved by the EC for the treatment of inflammatory conditions.
Sep 12, 2013
By PharmTech Editors

Hospira announced that its biosimilar monoclonal antibody (mAb), Inflectra (infliximab), has been approved by the European Commission (EC) for the treatment of inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. Inflectra, the biosimilar to the reference biologic product, Remicade, is the first mAb to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway.

"The rigorous scientific review and approval process by the EMA 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 authorisation 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, Hospira, in a press statement.

The EC’s approval of Hospira’s biosimilar mAb was based on the safety, efficacy and tolerability data from a comprehensive clinical trial programme. Inflectra demonstrated therapeutic equivalence in a Phase III randomized, double-blind trial. Results from the study showed that 73.4% of patients receiving Inflectra had a greater than or equal to 20% improvement in rheumatoid arthritis symptoms after 30 weeks of treatment compared with 69.7% treated with Remicade. The safety and tolerability of Inflectra was also comparable to Remicade.

In 2009, Hospira entered into an agreement with Celltrion, a biopharmaceutical company based in South Korea, under which Hospira obtained rights to Inflectra in Europe and certain countries in the Commonwealth of Independent States, the US, Canada, Australia and New Zeland.