Top Questions about Generics

Posted by Liam Honk on March 28th, 2021

What are generics?

Generic medicines, or “generics,” contain the same ingredients as the branded medicines. Such medications are distributed by Canadian Family Pharmacy through canadian-familypharmacy.com. Global delivery attracts many customers around the world. It takes several minutes to make an order. The parcel will be delivered to any corner of the world within the stated periods of time.

Generic medicines must have the same dosage form and treat the same diseases as the original drugs. Generic drugs must have bioequivalence, indicating that they act in the human body in the same way as the original drugs. Bioequivalence means that generics are interchangeable with brand-name drugs. Generics are produced when the patent for the original drug expires.

Is there any difference between generics and brand-name drugs?

Generic drugs contain the same active ingredients in the same concentration and dosage as the original drugs and act in a similar way in the human body. Their development, production, quality control and delivery conditions comply with quality standards similar to the original drug. Generics may differ from original drugs only in the composition of inactive ingredients (excipients), but this does not affect the bioequivalence and clinical effect of the generic drug.

What are the benefits of generics?

Generics meet the same stringent quality standards as the branded drugs, and are as safe and effective as the branded ones, but at a lower cost. The availability of generics means that people who cannot afford the original drugs are able to get the treatment they need. Generics provide significant savings to national health systems.

How do generics improve human health?

Generic drugs are cheaper than branded ones. They compete with brand name drugs and help reduce costs after or even before patent expires. In this way, generics help improve the availability of medicines in developed countries, thereby lowering health care costs in developing countries, where patients often cannot afford to buy branded drugs. In addition, these savings help free up health care resources in different countries to invest in innovative drug development.

Who verifies the quality, safety and effectiveness of generic drugs?

All medicines, generic and branded, must obtain approval from the European Medicines Agency (EMA) or FDA national drug agencies before they can enter the European and American Union market.

To obtain a registration certificate, generics must have bioequivalence with the brand-name drug, that is, they must have the same effect on the patient's body. The EMA or FDA evaluate bioequivalence based on the dossier of the original drug, as well as the results of bioequivalence studies, in order to draw conclusions about the safety and efficacy of a drug.

When a manufacturer submits an application for registration of a medicinal product to the EMA and FDA, it must prove that its constituents are pharmaceutically equivalent to the original product, and confirm through a bioequivalence study that all pharmacokinetic parameters are comparable to those of the original product.

Why is a bioequivalence test required?

According to the legislation, before registration and issuance of a certificate for a medicinal product, it is required to conduct its bioequivalence test to ensure the necessary safety and efficacy of the generic.

A bioequivalence test is a clinical study showing that the same amount of active substance is present in the human body for a certain period of time, regardless of which drug was taken, original or generic.

Are generics really as good as the branded drugs?

Yes, they are. Generics are similar to the original drugs. They contain the same active ingredients in the same doses as the original formulations, and are manufactured to the same stringent quality standards, with the same efficacy and safety. Like the branded drugs, generics are manufactured in factories that comply with Good Manufacturing Practice (GMP) standards and are periodically audited by regulatory authorities. In addition, since generics are on the market, the manufacturer must screen the product for side effects.

What is a patent?

A patent is a set of exclusive rights granted to an inventor for a limited period of time in exchange for a new product being made available on the market. In the pharmaceutical industry, a patent only allows a drug to be sold to the company that developed it. This exclusivity period allows the patent holder to offset its development and original drug costs to generate a reasonable profit. After the patent expires, it becomes possible to legally produce generic versions of the original drug. You can patent the formulation of a generic drug, but not its active ingredients.

How long does a patent for branded medicines last?

20 years for a standard patent - the same as in other industries. However, both in the pharmaceutical and other industries in the European Union, patents can be renewed for a further five years upon receipt of a Supplementary Protection Certificate (PSA).