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The Year of the Biosimilar Has Arrived. Now How Do We Name Them?

The Food and Drug Administration (FDA) recently approved the first biosimilar in the U.S. – Sandoz’s Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim). This approval launched a new industry where lower-cost biosimilars will create a competitive market potentially saving billions per year in drug spending in the U.S. However, important safety issues remain, including how to name these products.

Since biosimilar medicines are made from living cells, they cannot be exact copies of the “brand” product. So, how do we name these? The FDA continues to struggle with developing a comprehensive naming policy for these biosimilars.

In its approval of Zarxio, the FDA chose the name “filgrastim-sndz”—providing the drug with a suffix to form a unique name. However, the FDA has indicated that “filgrastim-sndz” is only a temporary solution, stating that it is an “interim” name and “should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilars and other biological products.”

Dr. Bert Petersen, director of the Breast Surgery Clinic of St. Barnabas Hospital states, “Ensuring easily distinguishable names for all biologics and biosimilars reflects the scientific fact that they are different products from one another. Clarity resulting from distinguishable names will enable better safety monitoring of adverse events through good pharmacovigilance.”
http://www.modernhealthcare.com/article/20150406/NEWS/304069980

Written By: Jacklynn A. Kment, MPAS, PA-C, SDPA Vice President




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