Higher costs do not necessarily mean better quality.
- a lower cost alternative
ARE THEY THE SAME?
Yes, Generic medicines are evaluated by Health Canada to confirm that they are bioequivalent to their respective brands, that is, they are equal in terms of safety, the way they function in the body, and have the same level of high quality similar to their brand-name counterparts.
generics cost an average of
less than brand-name drugs
Generic drugs accounted for 57% of all
Generics are every bit as safe and effective
as the brand-name drug
LEARN ABOUT GENERICS, INTRODUCTION TO GENERICS
An introduction to the basic concepts of generic drugs and how it relates to Canada, including its definition, composition, classification and approval.
Generic drugs - An introduction
A generic drug contains the same active ingredient (chemical responsible for the action of the drug) as the original formulation used in the brand-name drug. It also delivers the same amount of active ingredients into a person's body and works in the same manner as the brand-name drug. A brand -name drug is protected under a patent for a certain period of time. Once this patent expires, a generic drug can be produced by drug companies other than the original brand-name drug maker. To make and sell drugs in Canada, both brand-name companies and generic drug companies must follow the same Good Manufacturing Practices (GMP) guidelines and obtain a license.These guidelines ensure that the standards for drug development process and quality are maintained.
A brand -name drug, also known as reference drug, must prove its quality,effectiveness or clinical usefulness and safety through scientific methods (research studies involving animal and human participants) at the time of registration with Health Canada. When a generic drug proves that it is bioequivalent to the brand-name drug as per the highest international standards and requirements, it can be approved by Health Canada. Two drugs are said to be bioequivalent when both produce the same desired therapeutic outcome in patients
Generic drugs may look different from the brand-name drug due to the difference in certain inactive ingredients, such as colouring agents. Generic drugs are required to have the same active ingredient strength, comparable dosage form, and the same way of taking it into the body as the brand-name drug. However, they need not contain the same inactive ingredients as the brand-name drug. It is important to remember that these inactive ingredients do not affect the safety or effectiveness of the generic drug. Although generic drugs are chemically similar to their brand-name counterparts, they can be sold at a price as much as 90% lower than the brand-name drug.
Active pharmaceutical ingredients vs. excipients
Drugs are composed of active and inactive(excipients) ingredients. The active ingredient in a drug is also known as an active pharmaceutical ingredient (API) and is responsible for the good health benefits in the body when the drug is taken.
Excipients are components included in a dosage form (tablets, capsule, ointment, etc) other than the active ingredient. They contribute to the drug's qualities such as stability, flavour, appearance, patient acceptance and ease of manufacturing.
Difference between bioavailability and bioequivalence
When a certain drug is taken into the body, it is absorbed into the blood through various methods. The drug circulates in the blood and reaches the site in the body where it is required to act. For most drugs that are taken orally, the active ingredients are released in the digestive tract and arrive at their site of action via the blood stream. The rate and extent to which a drug reaches at the site of action is known as bioavailability. Bioavailability is assessed using two main variables; blood concentration over time and the maximum concentration of the active ingredient in the blood stream. The difference in bioavailability between the generic drug and the brand-name drug should not be more than 20%.
Bioequivalence is the international standard for determining if two drugs are similar enough to be used interchangeably. This means that they are equal in terms of dosage, safety, strength, quality, the way they work in the body and the way they are taken. To prove bioequivalence, the generic drug must deliver the same amounts of active ingredients into a patient's bloodstream, measured over time as the brand-name drug.
Health Canada considers a generic drug as bioequivalent to the brand-name drug if the bioavailability provided by both drugs is comparable. As it is normally not necessary to repeat clinical studies involving animal and human participants for generic products, bioequivalence studies are used instead of such clinical studies to obtain clinical effectiveness and safety data. For oral drugs, it is accepted that if concentrations of the active ingredient of the generic and brand-name drugs in the circulating blood are the same, then the generic drug will be similar to the brand-name drug in terms of safety and effectiveness. The bioequivalence standards in Canada have been maintained over the last 20 years and are amongst the highest standards in the world. Health Canada updates these standards at regular intervals so that they are in-line with the latest international regulatory approval guidelines.
Generics - The approval process
Health Canada is the primary department of the federal government responsible for national public health. It evaluates requests for permission to market generic drugs. The Health Products and Food Branch (HPFB) of Health Canada is responsible for determining the quality, effectiveness and safety of medicinal products as well as products that aid in detection of a disease approved for use in Canada.
To obtain approval to market a generic drug, the generic drug makers need to submit a written request known as an Abbreviated New Drug Submission (ANDS) to Health Canada. The request is termed "abbreviated" since data of testing in animals and humans is not required to establish their safety and effectiveness.
While safety and effectiveness studies are not required as part of the ANDS submission to Health Canada, generic drug makers are required to conduct comparative bioavailability studies. In these studies, healthy volunteers are given the brand-name drug and the new generic drug, at the same dose and in the same way. The concentration of the active ingredient in the blood is then measured to see if the generic drug delivers the same amount and at the same rate as the brand-name drug. Health Canada will then evaluate the ANDS and grant approval of the generic drug, based on a demonstration of equal safety, effectiveness, and quality to the brand-named drug.
Complex Generics- Expanding beyond simple generics
As described previously, a simple generic is a copy of a small molecule drug that is chemically similar to the brand-name drug. Complex generics, on the other hand, are a large and diverse group of products with complex active ingredients or formulations. These may be developed for the specific treatment of complex, long-lasting and life-threatening conditions such as cancer, rheumatoid arthritis etc.
Complex generics are classified into four categories:
- Complex Active Ingredients - e.g., peptides (compound consisting of two or more amino acids [chemical compound containing carbon] linked in a chain), complex mixtures, and natural source products
- Complex Formulations - e.g., emulsions (mixture of liquids not dissolving in each other), gels
- Complex Route of Delivery (path of drug intake) - e.g., locally acting (applied at the site where drug action is required) inhalation drugs
- Complex Drug -Device Combinations - e.g,. dry powder inhalers (DPI) and metered-dose inhalers (MDI) for asthma
Complex active ingredients can be further categorized into two types based on where the active ingredients were derived from:
- Non-Biological Complex Drugs (NBCDs): Are medicinal products whose active ingredients have been created chemically. NBCDs consist of different, closely related structures that cannot be separated, fully measured, identified and/or described by physical and chemicaI analysis.
- Biosimilars: A biosimilar is a biologic drug. Biologic drugs are usually copies of large,complex molecules or mixtures of molecules that are produced from living organisms or living cells using biotechnology. Biosimilars are highly similar to the originally approved brand-name biologic drug. Unlike generics, biosimilars are NOT identical to the brand-name drug. In Canada, the regulatory body for the approval of biologic drugs is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada. According to BGTD, a biosimilar is a biologic drug that enters the market after a version previously authorised in Canada, and has demonstrated similarity to a brand-name biologic drug.
- Myths and Facts about Generics
- Fast facts about generics
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