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Analysis

Bioequivalence Studies Shifting Generics Paradigm

Wed, 09/09/2015 - 15:28

Making bioequivalence studies a mandatory requirement was a necessary step that COFEPRIS took in 2010 to ensure quality and efficacy of generics in a market previously flooded by low quality drugs called similares. Mexican Norm NOM-177-SSA1-2013 establishes the necessary tests and methods to demonstrate interchangeability and biocomparability of drugs and biopharmaceuticals, respectively, as well as the requirements third-party laboratories must comply with to perform such studies. Interchangeability tests are scientifically sound studies including bioequivalence, bioavailability, and comparison of dissolution profiles, aimed to ensure that a generic medicine has the same quality, quantitative composition in active substance, and pharmaceutical form as the reference product – an innovative product facing patent expiration.

For any given generic medicine, third-party units and sponsors can only use one batch, while the reference drug must be determined by the sanitary authority. Both the testing drug and its reference must comply with the Good Manufacturing Practices, as established by NOM-059, and have quality control tests based on either the Mexican or international pharmacopoeias. Results from interchangeability studies are only valid for subsequent batches of the generic medicine obtained by the same manufacturing process. Moreover, clinical trials for such studies must be conducted under the quality and ethics standards established by the General Law of Health, Regulation for Health Research, Norm NOM012, CONBIOETICA, Good Clinical Practice, etc., and can be performed on either healthy volunteers or patients, depending on the nature of the medicines being evaluated.

The implementation of these requirements is directly associated to both the increasing levels of acceptance of generics among the population and the positive impact of Mikel Arriola’s Generics Policy, such as savings of US$1.53 billion in government expenditure, increased capacity to treat more than one million patients in the public sector, decreased out of pocket expenditure, and average price reduction of 61%. This has resulted in the pharmaceutical market comprising only two type of medicines: patented drugs and interchangeable generics.