After years of anticipation, the US Food and Drug Administration released a final guideline for naming both pricey biologic medicines and identical, but lower-cost versions that are known as biosimilars. However, the agency appears to have adopted a position that may give an edge to brand-name drug makers, a significant move given the huge sales that are at stake.
The guideline is somewhat cumbersome but, essentially, requires companies to add four-letter suffixes to the drug names that would allow physicians to distinguish between the original biologic and the new biosimilar. (A biosimilar, you may recall, is a distinct regulatory description for a medicine that is supposed to produce the same clinical result as a brand-name biologic.)
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