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Broad alliance queries FDA’s suffixes stance

Executive Summary

The US Food and Drug Administration (FDA) should clarify its current thinking on whether biosimilars and original biologics should addafour-letter meaningless suffix to the non-proprietary names of their products, according to a broad coalition covering biosimilar developers, health insurers, pharmacy benefit managers (PBMs), retailers, doctors, pharmacists and consumers. “Does this still represent the agency’s current thinking?” the alliance queries in a submission to a docket on facilitating competition and innovation in the biological products marketplace.

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