What is the advantage of generic drugs
questions and answers
The following information is not intended to replace advice from a competent pharmaceutical professional. If you have any further questions, please contact your doctor or pharmacy.
Why are generics cheaper?
It often takes up to ten years for a new drug to hit the market. Researching new chemical compounds, carefully investigating their effects and side effects, and selling them takes time and, above all, a lot of money. In order to recoup these high costs, original manufacturers receive a patent for up to 20 years. This patent guarantees an exclusive right to sell and market the drug. Generics are cheaper because the high investments in research and development are not incurred again in full. Marketing and sales are also cheaper because the active ingredient is already known to doctors. And because the active ingredient has been used and tested in therapy for years, not all expensive medical studies have to be repeated. This results in considerable savings that benefit our health system and thus the patients.
Do generics harm medical research?
A common misconception is that generics harm medical-pharmaceutical research and jeopardize medical progress. There is concern that the necessary investments in the development of new drugs could no longer be financed. The opposition from the original manufacturers is understandable. More generics mean that less profit is made on expired drugs. But that does not mean that less money is invested in research as a result. On the contrary: particularly in countries with a high proportion of generics, such as the USA (over 80 percent), research is particularly intensive. Why? Because the competition is greater there. In order to survive in the market, companies must invest more in research and development of new, innovative drugs. Generics are no competition for these innovative drugs, as they are again patent-protected for 20 years. The manufacturers of the original drugs are aware of this cycle and calculate their prices in such a way that the research costs are earned during the patent term.
Do generics contain outdated active ingredients?
Developing new drugs takes a lot of time and money. This is why original products receive up to 20 years of patent protection in order to secure investments in research and development. Only then are inexpensive copycat products - generics - allowed to be put on the market.
Whether an active ingredient is brought onto the market as a generic depends solely on its importance and its position in current medical therapy. Only drugs whose therapeutic benefit has been clearly demonstrated are eligible for a generic version. Generics are - according to the current status of medical therapy - modern, tried and tested drugs.
In addition to effectiveness and quality, safety is the most important criterion when choosing a drug. Effects and possible side effects of generics are particularly precisely and extensively documented due to many years of experience.
Do generics have the same effect as original drugs?
The active substance and the amount of the active ingredient in generic drugs are the same as in the reference drug. They can only differ in their auxiliary materials as well as packaging, color, shape, size and taste.
The Austrian Medicines Act, one of the strictest in the world, guarantees just as effective and tolerable treatment with generics. The same strict approval requirements apply to generics as to conventional preparations. Generics are also subject to the same drug safety and quality control guidelines. There is one exception: since generics only contain well-known and documented active ingredients, it is possible to use existing medical data for approval. The interchangeability between the usual preparation and the successor drug is guaranteed.
How are generics tested?
“Bioequivalence”, the interchangeability of drugs, is only given if they also have the same “bioavailability”. Bioavailability indicates how quickly and how much the human body absorbs a medicinal substance. To make sure that the original and the generic work equally well, we carefully examine how the active ingredient is absorbed by the body and excreted again. This guarantees that generics are as effective and safe as the original. Bioequivalence studies are carried out according to standardized international norms (see EMA) and are recognized worldwide.
What about the switch to generics?
The risk of taking generic drugs is no higher than that of taking regular drugs. Both drugs contain the same active ingredients in the same quality and dosage. The galenics (the theory of the preparation of medicines), on the other hand, is often optimized for generics. The advances in pharmaceutical technology are incorporated: Particular emphasis is placed on compatible excipients, additional dosage strengths and patient-friendly dosage forms. Of course, new auxiliary materials and further developed galenics are also subject to meticulous assessment by the Austrian approval authorities. In addition, the additional dosage strengths represent a further plus: The medication has to be taken less often. The often larger number of items per pack saves you on the prescription fee.
Are there generics for all therapeutic areas?
In principle, there are generics only for products whose patent has already expired. In Austria, however, we have generics in practically all indication areas. Generics are most beneficial when they are used to combat so-called "widespread diseases". Generics are available, for example, for most common chronic diseases. 48% of all prescriptions for heart and circulatory diseases are generics.
What are the advantages of using generics?
The great advantage of generics is that the costs for standard treatments are massively and permanently reduced. The quality of medical care is guaranteed over the long term. In addition to the savings effects, there are other advantages:
Generics only contain proven active ingredients. These are well known and documented due to many years of therapeutic experience. Generics are therefore among the safest drugs.
Generics are often manufactured under better production conditions than the originals because technical developments have made great strides in the years since the initial registration. This makes it possible to offer patients known active ingredients in an improved dosage form.
Where can I find out more about generics?
When it comes to such an important topic as pharmaceuticals, you shouldn't do without the advice of experts. Your doctor knows your individual medical history and decides which medication is best for the treatment with every prescription. You may not be made aware of the possibility of inexpensive generic treatment every time you do this. You can also take the first step and ask your doctor about generics.
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