Singulair and its Analogs
There was a question about the Singulair and its analogs. Let’s understand the essence of this aspect.
Generics are medications that have to be confirmed with pharmaceutical, biological and therapeutic equivalence to the original.
The drug should be almost similar to the original, provide the same clinical effect, and be as safe as the reference substance (original), whose effectiveness and safety are established.
The original drug is the first synthesized medication. Once the new drug is synthesized, it is recorded. Its effectiveness and safety should be exhibited on the basis of data from multicenter, randomized trials. The original product is ensured by a patent for reproduction (creation of generics) for up to 20 years.
Only after the patent expiration, any pharmaceutical company is eligible to reproduce the drug. Generics, for the most part, are produced with a poor quality. At one of the biggest factories in China, manufacturing the basic substances for the future medicine, you can make a substance at $ 50.00 per a gram”.
How does the Generic differ from the Original one?
- There is no patent protection;
- Relatively low price;
- Almost full compliance with the original product by composition (auxiliary substances may be different);
- Generics must match the main requirements (in fact – not always);
- Their production must meet not always all the standards of GMP (good manufacturing practice).
Thus, the advantages of original drugs are:
- proven effectiveness;
- confirmed safety;
- strict quality control.
The process of creating a generic is very different. There are no stages of clinical studies. They are generally minimal there. There is no cause of this if we do the same drug as the original? Before registration, only the bioequivalence study is carried out (ie compared with the original).
The quality of the constituents is also very important: any change in the composition of constituents or coating can significantly change the drug quality, its bioavailability, lead to toxic or allergic phenomena! It is a fact!
For example, the use of generic antibiotics can lead to chronic diseases, bacterial resistance to antimicrobial drugs, increased disability and mortality.
How is the problem of generics solved in developed countries?
- First of all, this is a strict quality control at every stage of the journey from producer to a patient.
- Colleagues in European countries and the US have free access to the Orange Book.
- In this directory, the generics are divided into groups “A” and “B”.
- Generics with the note “A” can be a substitute for the original drug for financial reasons! The doctor can freely prescribe them, if necessary.
- The drug with the note “B” cannot be an automatic replacement for the original drug or another generic from group A.
What should a doctor do if he wants to treat the patient qualitatively?
Most likely, prescribe the original drug, if available, or choose a high-quality generic product if it is impossible to prescribe the original drug, for financial reasons.
But we do not always know, whether this generic is good?
What should a patient do?
Start asking the right questions, and also stop saving on health! It is well known that people on dietary supplements spend 10 times more money than when buying drugs.
What should confuse you as a patient?
Probably, you should be confused by the low cost of the drug only. Moreover, you do not distinguish the original or generic? If only the doctor does not say so.
There are no distinctive signs on the packages. The company that makes the original drug spends a lot of money on its development and research! Therefore, such a drug cannot cost so few.