EMA Adopts Five Product-Specific Bioequivalence Guidances

The European Medicines Agency adopted five product-specific guidances, effective Jan. 1, 2018, outlining requirements for establishing bioequivalence, including clinical study design.

The products include HIV antiretroviral therapies and combinations, a treatment for major depressive disorder and a chemotherapy approved in non-small cell lung cancer.

The guidances include recommendations for Gilead’s elvitegravir antiviral, both alone and as a fixed-dose combination with cobicistat, emtricitabine and tenofovir under the brand name Stribild. The EMA recommends single-dose, crossover studies in healthy volunteers — one for the combination, but two for elvitegravir alone, at 85 and 150 mg strengths.