How does it work?

Bringing a new medication to the market is a complicated, lengthy, and costly process. The developer must conduct preclinical steps, several phases of clinical trials, pharmacokinetic studies, and study the physicochemical and biological properties of the drug. The drug is then tested on volunteers for a long time, and only after that, it is introduced to the market.

To have the exclusive right to sell it, the manufacturer patents it, and only after the patent expires (which can be up to 20 years) can other companies reproduce it under license.

It is much easier to produce a drug under license — in other words, a generic one that has already been tested by the original manufacturer and approved by regulatory bodies such as the Food and Drug Administration (FDA). There is no need to spend money on invention and efficacy testing. This also makes it possible to produce the drug in countries with cheap labor. All of this contributes to generics being cheaper than the original.

Company secrets

Laws regarding generics are strict in the U.S. Legally produced generics are produced under close supervision, and their bioequivalence to the original is always investigated. Ideally, the effect of generics should not differ from the parent drug. However the composition of any drug, in addition to the main active ingredient, includes a variety of ingredients. That is why when creating a generic, the most difficult task is the selection of excipients since they can change the nature of the drug. The quality of raw materials, which contain different amounts of impurities, and the production technology are also important.

Quality control is carried out by the company manufacturing the generic drug. A serious company conducts not only mandatory bioequivalence tests, but also pharmacokinetic tests, checking how quickly the drug is absorbed when its concentration in the blood reaches a maximum, and how quickly it is eliminated from the body.

Generics are a boon to health care because they make treatment more affordable and create competition in the marketplace. Always consult your doctor about which specific medication is right for your medical needs.

A good generic drug will have the following qualities:

• Not too cheap
• Does not have more contraindications than the original
• Requirements for generics are higher in the European Union and the United States, which means that medicines produced there are usually more effective and safer
• Look for the GMP mark — if the package bears this mark, the effectiveness of the generic is the same as that of the original

28 October 2021