Generic Drugs: Questions & Answers

Medications are expensive, and their prices continue to rise. One way to save money in a pharmacy is to use generics, cheap copies of popular drugs. Someone considers this an excellent life hack, and someone carefully avoids such drugs. Today, we will tell you how generics are made, how they differ from the originals, why they are cheaper and how they are controlled.

Generic Drugs_ Questions & Answers

What are generic drugs?

Generics are medicines that reproduce previously created drugs. They begin to be released when the patent on the original drug expires. Usually, this period lasts about 20 years, then the manufacturer is required to disclose a unique active ingredient formula. 

But there are also differences between the generic and the original. Copies contain a different set of excipients, and the technology for the production of ingredients differs. For example, a generic manufacturer may use raw materials with a different degree of purification. In addition to generics, there are bioanalogue medicines: these drugs do not reproduce “small molecules” (that is, chemical compounds of relatively small molecular weight) but large ones — for example, some proteins. They are created with the help of specially prepared cells: this process is much more difficult, and biological preparations cannot be considered exact copies.

Is the composition of the original and the generic different?

Yes, their compositions may vary slightly. The fact is that the developer company shares with other manufacturers only the formula of the active substance. The company is not obliged to talk about excipient, that is why there is a small amount of impurities in the composition of a generic because of the difference in production methods.

However, the body’s response to medications is individual, and it may happen that you have an allergy to excipients contained in an original medicine while a generic product is tolerated well.

Why are original medicines so expensive?

The manufacturers explain this by the fact that the development of a new medicine requires huge investments: it takes several billion dollars to create one medicine. The time it takes for specialists to find an active substance formula and the use of technology (such as supercomputers) are also expensive. The drug development and safety review cycle lasts several years and may fail at any stage. The patent that protects the formula of the new active substance and the relatively high price of the original medicine partially reimburse these costs.

But this is not the only factor affecting the cost of drugs. The policy of pharmaceutical companies also plays a role. Alas, sometimes unscrupulous manufacturers go to tricks in order to maintain high prices: for example, they pay potential generic manufacturers in exchange for a promise to postpone the release of an inexpensive product (this practice is called pay for delay). The situation is complicated when medicines for the patient are paid by the insurer – the state or a private company. In such cases, prices are affected by numerous factors and the final cost of the drugs is usually determined only after long negotiations. Each of the parties – the manufacturer, the insurer and the intermediaries between them – is trying not to miss the benefit, as a result, drug prices continue to rise.

What are generics tested?

Unlike the original drug, the generic does not need to undergo a full cycle of clinical trials. The creators of the original have already proven that their drug works and does not harm patients. According to WHO requirements, in order to launch a copy on the market, only three types of studies need to be carried out: to confirm that the medicine is made in the same dosage form (eg. tablets); to show that it is therapeutically effective, that is, it affects patients with a certain disease in the same way as the original; and finally to test the bioequivalence of the generic and the original.

This means that the analog enters the body in the same way as the original (for example, is swallowed), and is absorbed in the same way as it is. If the generic is absorbed at the same rate, at the same time reaches its maximum concentration in the blood, is also distributed in the tissues of the body and excreted as quickly as the original – this is quite enough.

How to understand whether I can trust the manufacturer of a generic drug?

A copy of the medicine goes through far fewer checks than the original, so you can mainly focus on the reputation of its manufacturer. There are generally accepted standards for the production of drugs – it is worthwhile to find out if the manufacturer of the drug complies with these standards. One of these core standards is GMP (Good Manufacturing Practice), a set of rules governing production conditions and quality control. GMP standards apply to many aspects of drug manufacturing: the purchase of raw materials, training and hygiene of workers, and even the conditions in which the drug will be stored in a pharmacy.

If the company has a GMP certificate of conformity, it is highly likely to be trusted. You can check whether the company has such a certificate on its website. Besides, the name of the manufacturer can be found in the online databases of the GMP website.

Another way to test a drug is to find it in the List of Authorized Generic Drugs compiled by the FDA (the American Food and Drug Administration).

Why do doctors prescribe generics?

Of course, each doctor prescribes medication taking into account the specific situation and based on his or her own experience. Someone avoids the analog drugs, someone does not see anything bad in them. But if the patient cannot afford the original, then an inexpensive generic is sometimes the only way to get the right medicine.

Therefore, in many countries, doctors are advised to ask the patient about the level of his or her income: this helps to build a treatment regimen taking into account the patient’s budget. This also works in the opposite direction: if you think that the necessary medicines may be too expensive, you should ask your doctor in advance about possible alternatives and whether it is possible to replace the original with a specific generic in your situation.

Who should not use analogs?

If the manufacturer complies with all production rules and carries out all the necessary tests, the generic can be considered as safe as the original. But sometimes this rule, alas, does not work, for example, with some serious illnesses. Often this applies to cases when the patient takes large doses of several different drugs at the same time – their effects can unpredictably overlap. Generics only add unknowns to this equation since the composition of their excipients may not be the same as the original.

This does not mean that in severe diseases you need to abandon generics completely – it all depends on the reaction of a particular patient. In addition, for some diseases, cheap analogs are the only possible option.

Why are there problems with the quality of generics?

Difficulties can be associated not only with the characteristics of rare diseases – sometimes the problem is in the drug itself. This may be due to attempts of the manufacturer to save on raw materials, excipients or due to violations of the rules for the drug production (for example, GMP standards). Such situations sometimes arise when a generic is produced outside the country: it is difficult for its regulatory authorities to monitor how the company adheres to quality standards.

A similar case occurred when the U.S. health authorities ordered generics of the drugs needed for HIV from the Indian company Ranbaxy Laboratories. Thanks to one of the company’s employees, it turned out that they had falsified reports and research results. Of course, this fact speaks about one particular company and not about Indian pharmaceuticals in general: India is the largest manufacturer of generics in the world, and there are no complaints about the many drugs released there. Such exception episodes only show how important international quality standards are.

Another problem is related to registration of generics: this is the lack of research and tests before putting it on sale. For example, the manufacturer checks the drug for bioequivalence but pays much less attention to tests of the pharmaceutical quality of the drug. But it is precisely these studies that provide confidence that the copy product contains the same active substance in the same amount.

What other problems can arise?

Even a high-quality and well-tested generic can fail if the patient has a prejudice against copy-drugs, reported scientists from New Zealand. They suggested that volunteer students take a new effective anti-anxiety medication, its brand-name counterpart and an inexpensive generic before exams: in fact, all three groups received a placebo. The “original” product calmed and lowered the pressure best, the “generic” did not help. In addition, those who took the “generic” complained of severe side effects.

So, should I use generics or choose the original medicine?

As in many other questions relating to medicine, the answer is as follows: each case is individual. It depends on the kind of disease, duration of treatment, the budget of the patient, etc. To find out if a particular copy drug is right for you, you should consult a doctor you trust and learn more about the manufacturer of the drug (for example, whether it has certificates of compliance with the rules for the production of drugs). But when choosing a drug, you should not be guided by user reviews on the Internet – a particular medication can help others but be completely useless for you, and visa versa.