Has European biotech history just been made?
The approval of Hospira's Inflectra by the European Commission means that Europe can welcome in its first biosimilar mAb, and the news could pave the way for more affordable generic biologics to hit the European market soon.
Inflectra is a biosimilar of Remicade (infliximab), and was developed by Celltrion in South Korea before Hospira obtained the European rights in 2009. The biosimilar antibody has been approved for the treatment of several inflammatory conditions, including rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis and psoriasis.
Biosimilars offer a more affordable treatment option to highly effective but very expensive branded biologics. "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.
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The approval of the first biosimilar mAb in Europe is a significant development in the industry, as expensive biologic therapies will face increased competition in the market. "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 news comes as the California State Senate passes a biosimilar bill in the state, amid divisions in the industry over the introduction of biosimilars in the US. Hospira has previously been named as one of the top 3 companies set to dominate the early stages of biosimilar introduction in the US.
If you're interested in hearing more about strategy and innovation in biosimilars, find out more about the World Biosimilar Congress Europe 2013, 12-13 November 2013, where Paul Greenland, Chair of the EGA Biosimilars Market Access Group, Vice President – Biologics, Hospira will be speaking on the entry of the first biosimilar mAbs in the EU.
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