BioCentury
ARTICLE | Politics & Policy

FDA issues biosimilar naming guidance, proposed rule

August 28, 2015 2:57 AM UTC

FDA released draft guidance and a proposed rule on biosimilar naming. Both documents propose to give each biological product a shared non-proprietary "core name" plus a unique four-letter suffix to associate biologic products with non-interchangeable biosimilars, but distinguish between them.

The draft guidance proposed that each biologic and biosimilar receive a hyphenated "proper name" joining two parts: a "core name," which FDA describes as a non-proprietary name containing scientific information about the compound, plus a suffix to differentiate among non-interchangeable reference products and biosimilars. ...