Hospira has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the European Commission (EC) approval of Inflectra (infliximab) for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.
Inflectra (infliximab) is a biosimilar medicine to the reference medicinal product, Remicade® (infliximab), and is the first monoclonal antibody therapy to reach a positive opinion following review via the EMA biosimilars regulatory pathway. A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic, with comparable quality, efficacy and safety to the reference product. Remicade® had European sales of over USD 2bn in 2012.
“Today’s announcement is confirmation that Inflectra has met the very rigorous quality, safety and efficacy requirements that have been established by the EMA, and provides the next step toward Inflectra being approved for use in Europe,” said Dr. Stan Bukofzer, Corporate Vice President and Chief Medical Officer, Hospira.
Biologic medicines have led to vast improvements in the treatment of conditions such as rheumatoid arthritis and inflammatory bowel disease, but they also represent one of the biggest medical expenditures in many countries.
“In a time when there is mounting pressure on healthcare budgets worldwide, Inflectra provides an opportunity to increase patient access to more affordable biologic therapy while maintaining high quality standards,” said Richard Davies, Senior Vice President and Chief Commercial Officer, Hospira.
Inflectra specifically targets tumour necrosis factor (TNF) alpha, a protein in the body that contributes to the painful inflammation seen in rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. The drug’s safety, efficacy and tolerability have been established through a comprehensive clinical trial programme. In a phase III randomised, double-blind study, Inflectra met its primary endpoint of therapeutic equivalence to the reference product. In the study, 73.4% of patients receiving Inflectra achieved a greater than 20% improvement in RA symptoms after 30 weeks of treatment (using the ACR20 scoring system), compared with 69.7% treated with reference infliximab. The safety and tolerability of Inflectra was also demonstrated to be comparable to Remicade, supporting its approval.
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, the United States, Canada, Australia and New Zealand.
The European Commission reviews the recommendations of the CHMP. The final decision on approval, usually granted within three months of CHMP opinion, will be applicable to all European Union (EU) and European Economic Area (EEA) countries.
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 U.S.-based company with biosimilars on the European market, including Retacrit™ which was launched in Europe in early 2008 and Nivestim™, which entered the European market in 2010 and Australian market in 2011.