By Kevin E. Noonan — On July 20th, the FDA released draft Guidance regarding its standards on therapeutic equivalence (TE) between both biologic and small molecule (NCE) drugs. The definition of "therapeutic equivalence" in the Guidance is: [A]pproved drug products that FDA has determined are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. The purported purpose of the Guidance and the standards set forth therein is to provide states, formularies, pharmacies, and the like in…
