Generics update: FDA releases new bioequivalence guidance
- The FDA has released specific testing protocols to prove bioequivalence on almost 40 drugs, including Gilead's Sovaldi (sofosbuvir), RAPS reports.
- Proving bioequivalence is a critical part of getting a generic drug approved and a crucial part of a company's abbreviated new drug application (ANDA) for a generic drug.
- When the FDA issues such testing protocols, it empowers generic manufacturers, because it allows them to conduct tests using specific protocols and significantly decreases development time and time to market.
The guidance is extensive and being well received by generics manufacturers. Included on the list of drugs are not only Sovaldi for hepatitis C treatment, but also guidance for Xtandi (enzalutamide) for prostate cancer, Olysio (simeprevir) for hep C, Truvada (emtricitabine) for HIV, Jardiance (empagliflozin) for diabetes, and dozens more.
To see a complete list, visit RAPS.
- Regulatory Affairs Professional Society FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi