Generic products - What are they and can we entrust our health to them?
Andrii Doroshenko, Head of Clinical Research and Monitoring Department, Darnytsia Pharmaceutical Company
The vast majority of medicines produced in Ukraine are generics. What are they? Are they effective? What are their pros and cons, and what are the myths about generics passed down through generations?
Generic - what is it?
Generic products are medicinal products that have the same active ingredient (active substance) as the original (branded) product and in the same quantity. However, such drugs are produced under a different trade name and often at a much lower price. Generic products meet the same quality standards as the original products.
Moreover, generics are available in the same pharmaceutical forms (e.g. pills, capsules, solutions) and dosages as the original products.
Among medical professionals, one often hears about the bioequivalence of generic medicines. What does this mean in layperson terms? It means that generics necessarily have the same bioavailability as branded drugs: that is, the active ingredient of the generic absorbs into the patient's body in the same amount and at the same rate as after taking original drug, and acts in the body in the same way, causing the same effects in terms of effectiveness and safety.
The production of generic products is regulated by the same quality and safety standards as the production of original products.
At the same time, generics are usually cheaper. And here the question arises, why? Perhaps because of their low quality? Not at all! The fact is that generic manufacturers do not incur the costs of fundamental research to discover a ‘new molecule’, its preclinical studies, the full cycle of all possible clinical trials, and marketing to ‘promote’ the ‘new molecule’ from scratch. These costs are borne by the companies which manufacture the original products. Thus, the duration of clinical trials can range from 5 to 10 years, and, accordingly, this significantly increases the costs incurred by the original drug manufacturers.
So, as a matter of fact, pharmaceutical companies manufacturing generics just reproduce a medical product with an already well-tested and known active ingredient. That is why the cost of generics is lower.
Advantages of generic products
The main advantage of generics is their price. Due to this fact generics make treatment more affordable for a wide range of patients.
At the same time, these drugs are as effective and safe as the original products. In addition, generics are subject to the same international standards of production and quality control as branded drugs.
In addition, the production of generic products, just like branded drugs, is controlled by state regulatory authorities. In other words, there is no difference with the original drugs as well.
It is interesting to note that the excipients in a generic may differ from the original drug. And as a generic product is usually developed many years after the original drug is created, more up-to-date and high-quality excipients may be used to manufacture the generic product, which may contribute to the stability of the product, safety and predictability of treatment.
The entry of generic products into the market helps to reduce prices for branded products and increase competition in the pharmaceutical market, which ultimately benefits consumers.
The blind spot of generics
Despite their many advantages, generics have certain restrictions.
First of all, it is about the time after which innovative medicines become most affordable to a wide range of patients. In its first years on the market, an original new drug is under patent protection, and generics are not allowed to enter the market. In addition, sometimes, due to patent disputes or regulatory requirements, generic products may not be available even after the patent protection of the original drug has expired. Therefore, generics do not enter the market immediately. Therefore, during the monopoly period of the original drug on the market, a certain innovative “molecule” may be unaffordable for many patients.
The quality of generic products may vary between manufacturers. Some manufacturers may not strive for high standards of quality and production, which may affect the efficacy and safety of the drug.
Another blind spot of generics, despite their widespread use, is still the lack of awareness of their pros and cons among some doctors and their patients. In particular, generics are considered to be less effective or of lower quality than branded products. This may be due to a lack of information or a bias due to lower prices.
In addition, there are a number of other ‘myths about generics’, which will be discussed below.
Top 5 common myths about generics
Myth 1: Generics have more adverse effects
Generics have the same active ingredients as branded products, so their adverse effects are the same and usually well established by the time generics are introduced to the market. At the same time, excipients may differ between generics and branded products. This can indeed affect the tolerability of the drug by certain categories of patients, including causing allergic reactions. However, it should be remembered that generics are brought to the market later than the original drug, when higher quality and safety standards can be applied. This may be reflected in the choice of excipients and manufacturing technologies for generic products.
Myth 2: Generics are manufactured in less reliable conditions
The manufacture of generic products is regulated by the same quality standards as the manufacture of branded products. Manufacturing facilities are regularly inspected and audited by regulatory authorities to ensure compliance with international quality and safety standards.
Myth 3: Generics operate slower or faster than branded drugs
Generics must be bioequivalent to branded drugs, which means they must have the same rate and extent of absorption in the body. This ensures the same rate of therapeutic effect.
Myth 4: Generics are cheaper because they are of lower quality
Generics are cheaper because their manufacturers do not have to bear the costs of inventing new active ingredients, testing them on laboratory animals, conducting a full cycle of clinical trials and marketing from scratch. This allows them to offer generics at lower prices with the same or sometimes higher quality.
Myth 5: Generics are only manufactured by unknown companies
Many large and well-known pharmaceutical companies manufacture generics. In addition, some companies manufacturing branded drugs also manufacture generic products.
However, you should pay attention to the manufacturer of the generic product. It should be a well-known company that has modern production facilities, works according to national and international quality standards (GMP) and complies with all regulatory requirements.