Real-world Evidence from a Narrow Therapeutic Index Product (Levothyroxine) Reflects the Therapeutic Equivalence of Generic Drug Products | FDA

Real-world Evidence from a Narrow Therapeutic Index Product (Levothyroxine) Reflects the Therapeutic Equivalence of Generic Drug Products | FDA

Real-world equivalence, just like clinical trial data, confirms that generic drugs are therapeutically equivalent to brand-name drugs.

Bioequivalence standards ensure that generic products approved by the FDA do not differ from brand-name products in safety, efficacy, or quality (including potency). A recent investigation of real-world evidence by FDA and academic scientists, covering a ten-year period, confirms that patients taking levothyroxine benefit equally from generic and brand-name drugs.