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Biosimilars Law Blog

Monthly Archives: October 2013

Posted in News & Events

Europe approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs

Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September.  Authorization of Remsima represents the first monoclonal antibody biosimilar, and the thirteenth biosimilar, authorized in the European Union. In the United States, the Food and Drug Administration is into

Posted in News & Events

FDA Activities During Government Shutdown

The U.S. Food and Drug Administration staff will continue User Fee supported activities and vital consumer protection activities during the government shutdown.  FDA staff, including review divisions and chief counsel’s office, will continue work on regulatory activities covered by user fees under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA),