What's The Big Deal About US Biosimilar Approval?

Law360, New York (April 27, 2016, 11:55 AM EDT) -- The U.S. Food and Drug Administration awarded its second-ever approval of a biosimilar to Inflectra on April 5, 2016. Developed by Celltrion Inc. and licensed to Pfizer Inc., Inflectra (infliximab-dyyb) is the first monoclonal antibody biosimilar approved in the U.S. and was created for the treatment of arthritic and inflammatory conditions, such as rheumatoid arthritis and inflammatory bowel disease. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to the reference product notwithstanding minor differences in clinically inactive components. Also, to be biosimilar means there are no clinically meaningful differences between...

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