Biosimilars Mark Milestone In Europe With Regulators' Nod

Law360, New York (June 28, 2013, 3:53 PM EDT) -- European regulators on Thursday recommended approval of biosimilar drugs from Hospira Inc. and Celltrion Inc. that are more complex than any others previously cleared for sale, a milestone that heralds possible patent suits and serious competition for pricey brand-name biologics.

The blessing from a committee of the European Medicines Agency marks the first time so-called monoclonal antibody biosimilars have won endorsement in a developed region. If formal approval comes through for the biosimilar version of infliximab — known as Inflectra at Hospira and Remsima at Celltrion...
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