Pharmaceutical Journal (06/11/15) Murphy, Bernard

As more biosimilars are approved, different jurisdictions have adopted a variety of naming systems. A global unified naming system is central to ensuring the safe use of biosimilars, such as identifying the product in the clinical setting and tracing it after it reaches the patient. The World Health Organization's (WHO's) International Non-proprietary Name program is working on the project. WHO has proposed a unique identification code for all biological medicines that would include a four-letter suffix called a Biological Qualifier (BQ). The BQ would result in names such as “filgrastim-bcdf,” and would be attached to the manufacturing site where the biosimilar is made. The system would include creation of a database to hold all the codes issued. Several organizations have spoken out against the BQ system. Industry groups point out that a company could have two different codes for the same biosimilar manufactured at two different sites. Other groups say it could increase the risk of confusion and pharmacovigilance errors, and reduce competitiveness. The U.S. Food and Drug Administration is drawing up its own naming system, with a plan to issue draft guidance on the “non-proprietary naming for biological products” this year.

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