Hospira announces EC approval of Inflectra, Europe's first biosimilar mAb therapy

Hospira (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today announced the European Commission (EC) approval of Inflectra™ (infliximab), 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. 

Inflectra is a biosimilar medicine to the reference medicinal product, Remicade^® (infliximab), and is the first monoclonal antibody (mAb) to be approved through the European Medicines Agency (EMA) biosimilars regulatory pathway. A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic. Remicade recorded European sales of over USD 2 billion in 2012.

"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 Dr. Stan Bukofzer, Corporate Vice President and Chief Medical Officer, Hospira.

The use of biologic medicines has led to vast improvements in the treatment of conditions such as RA and IBD (inflammatory bowel disease), but these drugs are also responsible for some of the highest medicinal costs for many countries. The introduction of biosimilar mAbs in Europe is expected to deliver savings of up to €20.4 billion by 2020, with the biggest savings predicted in France, Germany and the UK.

"Inflectra offers physicians, patients and healthcare systems a more affordable treatment option, while maintaining similar quality, efficacy and safety to its reference product. We are confident that with lower drug costs, Inflectra can provide an opportunity for European Union health systems to manage their budgets more effectively, supporting Hospira's commitment to provide patients with better access to high-quality, more affordable care," said Richard Davies, Senior Vice President and Chief Commercial Officer, Hospira.

Inflectra was approved by the EC following review of safety, efficacy and tolerability data from a comprehensive clinical trial programme. In a phase III randomised, double-blind study, Inflectra met its primary endpoint of therapeutic equivalence to Remicade. In the study, 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment (measured using the ACR20 scoring system), compared with 69.7% treated with Remicade. Safety and tolerability data also demonstrated Inflectra's equivalence to Remicade. The most common side effects are viral infections, headache, upper respiratory-tract infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain.

In 2009, Hospira entered into an agreement with South Korean-based biopharmaceutical company, Celltrion, which is developing eight monoclonal antibody biosimilars. Under the terms of the agreement, Hospira obtained the rights to Inflectra in Europe and certain CIS (Commonwealth of Independent States) countries, the United States, Canada, Australia and New Zealand. Inflectra will be launched throughout Europe at the earliest opportunity taking into account any relevant patent protection.

Hospira has many years of experience in the field of biologics and one of the largest biosimilar pipelines in the industry. It is the only US-based company with biosimilars on the European market, including Retacrit™ (epoetin zeta) which was launched in Europe in early 2008 and Nivestim™ (filgrastim), which entered the European market in 2010 and Australian market in 2011.