FDA releases 37 new bioequivalence studies
- The FDA has released 37 new bioequivalence standards for a variety of drugs. The standards were created to facilitate development of abbreviated new drug applications (ANDAs) for certain products.
- ‘Bioequivalence’ is the absence of a significant difference between the extent and rate of absorption (bioavailability) of two pharmaceutical drug equivalents over a period of time.
- The FDA has also revised 12 other bioequivalence guidelines, including guidelines for generic versions of Cymbalta, Gleevec and Viramune.
Currently, the FDA has cataloged more than 1000 bioequivalence (BE) recommendations. BE recommendations provide a roadmap for generic drug companies, establishing standards such as the number of BE studies needed for approval, the most appropriate study designs and the scientific parameters of BE.
These recommendations greatly help generic drug companies, which are most concerned about proving BE in a way that is acceptable to the FDA.
- Regulatory Affairs Professional Society FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs