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Generic drugs: Questions and Answers

What is a generic drug? A generic drug is made from the same molecule as a drug that has already been authorized, known as a reference drug, for which the patent has fallen into the public domain. It has the same qualitative and quantitative composition inactive ingredients, the same pharmaceutical form, and it has demonstrated its bioequivalence (it behaves in the same way in the body). It, therefore, has the same therapeutic efficacy as the reference specialty, while its cost is lower. Where can I find information on generic drugs? You will find information on the National Agency for the Safety of Medicines and Health Products (ANSM) website as well as on the public database of medicines. The ANSM is responsible for the evaluation, laboratory control, and inspection of generic specialties. Like any pharmaceutical specialty, a generic thing must be the subject of marketing authorization (AMM) before it is marketed. The ANSM issues the MA as part of a national procedure, a European mutual recognition procedure, or a decentralized procedure. The decisions to register in the directory of generic groups (or to modify the directory of generic groups) are the subject of an official publication on the ANSM website. The list of authorized generic drugs is available in this directory on the ANSM website. Groups classify the specialties appearing in the handbook. Each group has a reference specialty and its generics.

Are generic drugs effective?

A generic drug contains the exact same active ingredients, in equivalent quantities, as the brand-name drug to which it corresponds. Its absorption, diffusion in the body, and effectiveness must be similar to those of its model. But this strictly rational approach is sometimes called into question. ARE GENERIC DRUGS AS EFFECTIVE AS BRAND-NAME DRUGS? Sometimes a patient finds the action of a generic less effective than that of the brand-name drug to which he was accustomed. Is it just a prejudice, a distorted perception of reality? Even if they are by definition impossible to verify, such statements deserve in any case to be heard and respected by doctors and pharmacists. To be effective, generic drugs must be used according to the same rules of good practice as other drugs: respect for dosages and times of intake, respect for modes of administration (on an empty stomach, with a meal, etc.), and respect the duration of treatment. Just because generics are cheaper does not mean that they are wasted. ARE GENERICS THE SUBJECT OF CLINICAL STUDIES? The marketing authorization which allows the marketing of a generic drug is based on the safety and efficacy data obtained with the original drug. Clinical studies to confirm this efficacy are therefore not necessary. However, as the form and excipients in generic drugs are not always identical to those of the original drug, studies are done to ensure that the generic drug is well absorbed and then eliminated under the same or very similar conditions—those of the original drug.

The price difference between generic and brand-name medications.

Generic drugs are, on average, 30% cheaper than brand-name drugs. This price difference can go up to 40 to 50% for the most recent generic drugs. They saved 3.2 billion euros in 2018 alone and nearly 27 billion euros since 2000. THE PRICE OF GENERIC DRUGS As for all drugs in France, their price is subject to negotiation between the manufacturer and the Economic Committee for Health Products (CEPS), which represents the State. Generally, when generic drugs from a generic group are marketed, their price is set 60% below the original price of the original drug (originator). At the same time, the cost of the original drug drops by 20%. Further reductions in the price of generic drugs and the original drug are imposed after 18 months, then regularly according to health insurance expenses. As a result, when generic drugs are newer, they can be almost 50% cheaper than the brand-name drug, but after several years the brand-name drug's price gets closer and closer to that of its generics. The price difference between generic drugs and brand-name drugs can be explained in particular by the very high costs of research and development, which precede the marketing of a new drug and which the laboratories pass on to the selling prices of the drugs. These costs do not exist for generic manufacturers, which allows them to sell at a reduced price. In some groups generics, drugs generics are not refundable, as the original drug. In this case, their selling price is free.