What is the difference between generic, bioequivalent and brand?

Since 2014, the “New Drug Law” has been in force in our country, which establishes, among other points, the obligation of physicians to write down the generic name of a medication when writing a medical prescription. Likewise, it dictates as a requirement for pharmacies to have bioequivalent drugs for sale. Until the publication of the law in Chile, there were 341 medicines recognized by the “bioequivalent” seal.

Beyond the fact that each patient or consumer must evaluate the price of these different types of medication, which by law must be explicitly indicated on the packaging, it is important to know the differences regarding the pharmacology of these categories.

What is the difference between generic, bioequivalent and brand? Is a generic drug of lower quality than a brand-name drug? What does it mean that one medicine is bioequivalent with another?

Before clarifying these doubts, we must know basic concepts such as: chemical, drug, medicine and drug. To learn these concepts in a playful way we prepared a crossword puzzle (in Spanish) that must be solved with the following concepts:

Clues to solve the challenge

VERTICALS

1. Practically everything around us, whose fundamental structure is atoms. The correct term is “chemical substance or  chemical product” and is understood as any substance, alone or in the form of a mixture or preparation, whether manufactured (synthetic or artificial) or obtained from nature, excluding organisms alive. They are often given a negative or toxic connotation, but their effect can be neutral, positive, or negative.

2. According to the Chilean Ministry of Health (Article 7, Decree 3/2010), it is defined as: a pharmaceutical product is any substance, natural or synthetic, or a mixture of them, that is intended for humans for the purposes of healing, attenuation, treatment, prevention or diagnosis of diseases or their symptoms, to modify physiological systems or mental state for the benefit of the person to whom it is administered. They are therapeutic tools used in the practice of medicine. They are also called “pharmaceutical drugs” .

3. Type of medicine whose manufacturer has developed a research process that guarantees its efficacy, quality and safety in clinical use, in doses and defined pharmaceutical form * . These drugs are generally used as a reference for generic development . Its commercial name is different from that of the active ingredient ** and they are also known as “innovative medicine” .

**Active ingredient: any biologically active substance or mixture of substances used in the production of a medicine, intended to exert pharmacological, immunological or metabolic action. They are mostly by-products of microbial, plant or animal origin.

4. Medicine that contains the active substance in the indicated quantity, but has not shown bioequivalence * . They are named the same as the active substance. Their information on efficacy and safety is based on the literature of brand name or innovative medicines. Without a therapeutic equivalency study , the same behavior cannot be guaranteed.

**Bioequivalence: Pharmaceutical equivalents or alternatives for which its bioavailability ** is similar to such an extent that its effect is essentially the same. The test is performed at the same dose and under the same conditions.
** Bioavailability: amount of active ingredient released from a pharmaceutical form, which enters the systemic blood circulation. It also refers to the speed of this process ( Cmax and tmax ) and the extent of absorption (AUC).

HORIZONTAL

1. Medicine with the active ingredient in the indicated quantity and which, through therapeutic equivalence studies , has been shown to behave similarly to the reference medicine (brand or innovative). In Chile, by regulation, its box (outer or secondary packaging) has a yellow band and the label written in red .

2. Biologically active molecule that, due to its chemical structure, can interact with protein receptors on the outer membrane or in the nucleus of cells, which triggers its effect. It can be of natural or synthetic origin. The term is narrowed to substances of clinical or medical interest , while the word “toxic” refers to accidental or intentional use, not intended for use in medicine , and that generates damage. It is also distinguished from a food since it does not provide nutrients. Likewise, the term “drug” refers to substances, natural or synthetic, for social use whose consumption is intended to alter mood.

3. Substance that causes changes in physiology or psychology when consumed. In pharmacology, its definition as “pharmaceutical drug” is equivalent to that of drug , it is also called medicine or medication , and is used to prevent, diagnose, treat, or cure a disease or promote well-being. In a social context, “drug” is associated with medication and “drug” with molecules that cause addiction.

Did you manage to complete the crossword puzzle and solve the challenge? Here is the solution:

If you have any questions, feel free to contact us .

References:
New Drug Law, February 2014, Ministry of Health, Government of Chile.
Guidelines from the World Health Organization.
FDA (Food and Drug Administration), United States.
Note: The definitions referred to in this publication are valid for Chile, in other countries the drugs known as generics are bioequivalent. In terms of commercial value, a bioequivalent can be cheaper than the innovative medicine, since in Chile there are brand-name bioequivalents and generic bioequivalents.
If you need to search for bioequivalents in Chile, enter http://bioequivalente.ispch.gob.cl/