Novartis, Teva May Get Sales Boost From New EU Rules
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Europe’s drug regulator set out guidelines for copying some of the most expensive biotechnology medicines, giving companies such as Novartis AG and Teva Pharmaceutical Industries Ltd. access to a $36.4 billion market.
The European Medicines Agency’s draft regulation, posted today on the agency’s website, aims to clarify how drugmakers can copy and sell so-called monoclonal antibodies after they lose patent protection. The document is open to public comments until May 31, the London-based agency said.