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FDA released its long-awaited biosimilar naming draft guidance Thursday (Aug. 27) in which it says it will use suffixes as part of nonproprietary names for biosimilars and reference biologics. The four letter suffixes will be non-meaningful, which is different than the provisional name FDA gave to the first U.S. biosimilar approved in March -- Sandoz's filgrastim-sndz. In addition to the draft guidance, the agency released a proposed rule that would rename six biologic products -- including the first Sandoz's product -- in accordance with the draft guidance.
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