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 the biological product and the reference product in terms of the safety, purity and potency of the product. In this case, Inflectra is a biosimilar to Remicade, a Janssen Biotech product which has been on the market since 1998 and reported U.S. sales of $4.45 billion in 2015....

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