Bioequivalence and Bioavailability Forum

Dear Munish,

first see (and adhere to)

• the Forum’s Policy here and there,
  
• as well as this post.

❝ What is the Bio equivalence criteria for generics drugs in Russia and Mexico (Specifically for highly variable drugs)?

See the guidelines: Russia, Mexico. Nothing specifically is stated about HVDs/HVDPs in both. The Russian GL even suggests only 2×2 cross-over designs – although I’ve hard in May this year that in the new draft scaling according to EMA’s method might be possible in the future.

❝ Do we need to conduct the BE study on mexican and russian population only?

Nothing stated in the Mexican GL, but according to “Lex Putin” all BE studies have to be performed in Russian CROs. Since the clinical capacity of Russian CROs is limited, I know that some sponsors split large studies in such a way that only a part is performed in Russia.

❝ Which innovators (reference) products should be used in Mexico and Russia for BE study? Can we make use of US innovator in study in Mexico or Russia?

Mexico:

4.14. Medicamento de referencia, al medicamento indicado por la Secretaría de Salud como tal, que cuenta con el registro de dicha dependencia, se encuentra disponible comercialmente y es seleccionado conforme a los siguientes criterios:
4.14.1. Medicamento innovador. En caso de no existir, cualquiera de los siguientes en el orden en que aparecen:
4.14.1.1. Producto cuya bioequivalencia esté determinada.
4.14.1.2. Producto que cuente con el registro más antiguo ante la autoridad sanitaria y que haya demostrado su eficacia y seguridad.
4.14.1.3. Producto con una correlación in vitro - in vivo establecida.
(homework: copy & paste to translate)

Russia:

As a reference formulation, there should be used a relevant original medicinal product, if registered in the Russian Federation, or its equivalent, if its bioequivalence to the original medicinal product has been established before and it has been successfully used in the healthcare establishments of the Russian Federation. The outcome of the bioequivalence study of the medicinal product registered in the manufacturing country can be considered acceptable, if the original medicinal product served as a reference product.