Generic medicines are those whose functionality is equivalent to that of an innovator product due to the fact that their patent has already expired, so they can be marketed without any problem. Then, the following question arises: do generic medicines work the same as reference ones?
According to the U.S. Food and Drug Administration (FDA), the similarities of both types of drugs in aspects such as; dosage, safety, potency, route of administration, quality, performance characteristics and intended use, helps to demonstrate the bioequivalence of the products, meaning that the generic medicine performs the same clinical function as the innovator product.
The FDA stated that, “any generic medicine created with an innovator product as a model must have the same effects in the body. Generic medicines use the same active ingredients as the reference ones and work in the same way, so they have the same risks and benefits.”
In the case of the United States, the FDA’s Generic Drug Program carries out a rigorous control to ensure that generic medicines meet all the standards, inspecting up to 3,500 manufacturing plants per year. This is replicated in several countries around the world, so that the quality and safety of these medicines are assured, as long as they are manufactured in plants that comply with all the GMP (Good Manufacturing Practices) established by WHO.
A study by Fundación Carolina of Spain, carried out in three South American countries (Argentina, Brazil and Uruguay), determined that it is essential to strengthen public policies for the supply of generic medicines, i.e., to stimulate the production, registration and marketing of these medicines. The document also states that incentives for the prescription and provision of these products should be incorporated to facilitate their access to the population. It is important that governments promote prescription policies so that doctors can use the international nonproprietary name in their prescriptions and avoid a link between doctors and laboratories. In this way, citizens will be able to choose the same active ingredient recommended by the doctor from a variety of brands and prices.
On the other hand, the United Nations (UN) reported that a agreement was reached for the production of a generic treatment for HIV prevention in low-income countries. This shows that the struggle being undertaken by some international organizations, governmental entities and private companies is bearing fruit. The goal being that generic medicines can be within the reach of the most vulnerable population.
The entity’s bulletin points out that, “the alliance for the voluntary licensing of patents related to long-acting Cabotegravir, an injectable antiretroviral medicine for HIV prevention, or pre-exposure prophylaxis (PrEP), will help facilitate access to generic formulations of the product in less developed, low-income, lower-middle-income and Sub-Saharan African countries.”
A generic medicine, according to the FDA, is equivalent to the innovator product in terms of dosing, safety, effectiveness, potency, stability and quality, as well as how it is taken and how it should be used.
Highlight
The FDA states that, “generic medicines use the same active ingredients as the reference ones and work in the same way, so they have the same risks and benefits.”
Figures
3,500 drug manufacturing plants are inspected per year in the United States.