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What is nonproprietary naming of biological products?
What is a nonproprietary name?
Why do biosimilar products have a nomenclature?
What are 'proper names' in biosimilars?
1 “Proper Name” means the nonproprietary name designated by FDA in the license for a biological product licensed under the PHS Act (see 21 C.F.R. § 600.3(k)). The proper name generally reflects certain scientific characteristics of the product, such as chemical structure and pharmacological properties.
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Jan 15, 2017 · Under the naming convention provided in the final guidance, “the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix .”
Nonproprietary Naming of Biological Products is the final version of a draft guidance for industry originally released in 2015. Under the naming convention outlined in the guidance, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name with two parts:
Apr 23, 2019 · In January 2017, it released its guidance on nonproprietary naming of biological products, proposing that all biological products — reference products and biosimilars alike — receive unique...
Aug 8, 2020 · Article. Bevacizumab-bvzr…pegfilgrastim-bmez…infliximab-axxq…. Have you ever wondered what is behind the seemingly random letter strings attached to the nonproprietary names (also known as “proper names”) of these biosimilars? The short answer is that they are used to distinguish a biosimilar product from the original biologic product.
Oct 21, 2019 · Biologics and biosimilars are both FDA-approved medicines that help patients treat or manage debilitating diseases. All biologic drugs, including biosimilars, are given an international non-proprietary name (INN). In addition to an INN, biosimilars are given a random, four-letter suffix.
Mar 15, 2018 · Generics, more affordable alternatives to their brand name counterparts that have identical active ingredients, are identified by their International Non-Proprietary Name (INN) (a unique name designated by the World Health Organization (WHO) that identifies the active ingredient in a drug) and share the same INN as the brand product.
