EU Approves Hospira's Inflectra In Biosimilars Milestone

Law360, New York (September 10, 2013, 7:03 PM EDT) -- Hospira Inc. on Tuesday said the European Commission has approved Inflectra, its copycat version of Johnson & Johnson’s blockbuster biologic drug Remicade, marking a historic day for development of highly advanced biosimilars.

Clearance was expected after European Medicines Agency officials earlier this year gave their blessing to Hospira's version of infliximab, a so-called monoclonal antibody drug that is more complex than any of the biosimilars previously approved in Europe.

Dr. Stan Bukofzer, chief medical officer at Hospira, called the authorization a "major milestone for Inflectra and...
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