FDA Implements Naming Regulations for Biosimilars


The Center for Biosimilars reported late last week that the Food and Drug Administration has started implementing its long-delayed naming regulations for biosimilars. The hotly debated process will add a 4-letter suffix, devoid of meaning, to the end of newly approved biologics’ non-proprietary names. The move reflects a change in previous policy that only added the suffixes to biosimilars’ non-proprietary names.
http://www.centerforbiosimilars.com/news/fda-implements-longawaited-biological-product-naming-regulations

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