A generic drug is a strict copy of an original or a brand name drug product for which a patent has entered in the public domain. Once the patent or patents have been expired, other pharmaceutical firms are allowed to manufacture and to market the same drug under an International Common Denomination (ICD) name or a different brand name. In some instances and by political choices and for public health policy, special arrangements may be obtained on drugs that are still protected by valid patents to accommodate public health interest to be produced by generic manufacturers. For example, several AIDS and hepatitis drugs have been authorized to be manufactured by generic drug firms for patients in developing countries. A generic drug must meet the same standards of efficacy, quality and safety than an original drug to be approved by health authorities. It is regulated by the same regulatory agency in most countries. In French Sub-Saharan Africa, the Direction de la Pharmacie et du Médicament, DPM within the Health Ministry, is the regulatory body for both innovative and generic drugs. However, a generic drug may slightly differ from the brand drug with regard to its presentation (format), its physical appearance, its marking usually the branding sign, its packaging, its labelling, its composition in terms of the nature of excipients (colouring and/or flavouring agents, preservatives, etc.). It also may bear a different expiry date. Since the branded drug has generally been on the market for several years when the marketing application is filed by a generics manufacturer, considerable information on the safety and efficacy of the brand name product is already available. This means that clinical studies for a generic drug are limited to Bioequivalence studies. A bioequivalence study is a clinical study where a generic drug and a branded drug are compared in two healthy human volunteer groups. The first group receives the generic drug and the second group the branded drug. The volunteers and the physicians, in charge of the study don’t know which group is receiving the generic drug nor the group receiving the branded drug. This is why these studies are called double-blinded. To be acceptable, the concentration of the drug in the serum at each point in time of the generic drug must be comparable to the branded drug. The results of these bioequivalence studies are part of the approval process of generic drugs by regulatory authorities, such as US FDA, Health Canada, European Medicine Agency (EMA) or DPM in French Sub-Saharan Africa. However, in certain developing countries, only in vitro, i.e. laboratory tests, are required to accept a generic drug. It is generally accepted that in vitro tests may not be sufficient to demonstrate bioequivalence. During the development and the production, a generic drug must adhere to the same level and rigorous standards of quality, safety, and efficacy as a branded drug. In addition, as for a branded drug, all production facilities used to make the generic drug must meet current Good Manufacturing Practices, cGMP. These facilities are regularly inspected by regulatory authorities such the US FDA, Health Canada, to ensure and to enforce the highest quality standards. Regarding the development of a generic drug, the manufacturer of a generic drug does not have access to the non-clinical data of a branded drug. In general, branded drug data is never revealed to third parties, including a generic manufacturer. Therefore, generic drug manufacturer must proceed with a formal research and development program to discover their own formulation, i.e., their own recipe of manufacturing the product. However, they may refer to published clinical data concerning the safety and efficacy of the reference product. Generic drugs are offered at significantly discounted prices than branded drugs because initial basic and clinical research programs do not need to be repeated in full for generic drugs. These cost savings are reflected on price paid by insurers and/or by patients. The demand for pharmaceutical products is increasing globally. This is driven mainly by a steadily increasing life expectancy, economic growth and technological progress worldwide as well as an aging population in developed countries. Consequently, healthcare costs are continuing to rise year after year. Public officials and health professionals worldwide are realizing the importance of promoting generics and are acting accordingly. The French Sub-Saharan Africa is following the same trend although lagging a bit behind. Certain developed countries like Canada have not only a long history and experience of successfully using both innovative and generic drugs but also have developed from years a secure pharmaceutical industry supply chain. We think that there are lessons that can be learned from these countries by developing countries such as Sub-Saharan Africa countries. We urge patients to use official distribution channels of drugs in Africa, for example by buying drugs at the pharmacy or official drug stores with valid permits. The attempt to use less costly drugs can lead to the use of fake drugs with a high risk to even harm more patients. Patients should rely on their healthcare professionals such as physicians, nurses, pharmacists, etc., to have access to safe drugs whenever possible. Cheaper generic drugs may be an indication that such drugs may not meet international quality standards. Patients should be cautious when buying such drugs. This article was prepared and edited by Dr. Jean-Pierre Metabanzoulou, Ph.D., MBA. He holds a Ph.D. in Chemistry from the University Louis Pasteur of Strasbourg in France, and a Master of Applied Chemistry from the same University. He also obtained a Master in Business Administration at Queen’s School of Business in Kingston, in Canada. He did his postdoctoral studies at the Institute of Inorganic Chemistry and Analytical, ICMA, of the University of Lausanne in Switzerland. After a short academic career, Dr. Metabanzoulou works for over 20 years now in the pharmaceutical industry in the private sector both for the innovative pharmaceutical industry and generic in Canada, in Switzerland, in France as well as in Africa.
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By Jean-Pierre Metabanzoulou|2020-05-23T09:25:53-05:00May 13th, 2015|Health & Wellness|0 Comments