Lovenox and Copaxone are regulated by the FDA as small-molecule drugs; under Hatch-Waxman, interchangeability of approved generic versions of these drugs is automatic.
Humira, Orencia, and Erbitux, on the other hand, are biologics that are regulated by the new 351(k) pathway, where interchangeability is determined by the FDA on a case-by-case basis according to the scientific support for interchangeability in the sponsor’s application.
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