Biological drugs are divided into reference drugs (original drugs) and biosimilars. The Ministry of He alth explains that there is no difference between them, that they are almost the same drugs. Meanwhile, it almost makes a difference. Why can't an equal sign be placed between reference biological medicines and biosimilar medicines?
Video source: NewsrmTV
Biological drugsis a large group of drugs for which an active substance is produced by living organisms. This group includesreference drugs(original) andbiosimilars , which are wrongly called generics. “Biosimilar” sounds negative to most of us, because we associate this name with something worse than the original, something like a chocolate-like product. However, our term "biosimilar drugs" is a literal translation of the English "biosimilar drugs" and in the European Union it is the official name for this group of drugs.
Biological drugs have been known for a long time. It is enough to mention drugs as popular as: insulin (diabetes treatment), heparin (heart attacks, thrombosis), growth hormone (short stature) or erythropoietin (anemia). The use of advanced technologies (biotechnological processes) made it possible to obtain new drugs - hormones, cytokines, stem cells, autologous and allogeneic cells, DNA vaccines, therapeutic genes, etc.
Original biological drugs: patent protection ends
Patent protection is ending for many original biological drugs. This means that similar drugs will also be able to be produced by other manufacturers. But it is not that simple. There is no equality sign between biological and biosimilar medicines, as is the case with generics and their original counterparts. Why?
It will be easier to understand this difference if we follow the manufacturing process of chemical drugs. If the active ingredient in a chemical drug is acetylsalicylic acid, the same substance will be found in both the original drug and the generic drug. Generic is distinguished from the original drug by auxiliary substances, e.g. tablet mass. The therapeutic value of both drugs will be the same. It is a bit different with biological medicines. Their therapeutic value is influenced by each stage of the manufacturing process - filtering, cleaning, freezing, heating, mixing withcarriers of the active substance and many other activities give the drug unique properties. Therefore, biological products produced under different conditions (e.g. air purity) or processes cannot be identical. Even with all technological rigors.
Manufacturers of biological drugs are the owners of the production process and, even after the expiry of patent protection, they keep their secrets, but thanks to this they can deliver preparations with uniform properties to the market. Manufacturers of biosimilars will also try to comply with all production rigors, but this may not be enough. In many cases, it is still unknown what determines the therapeutic usefulness of biological drugs. Especially in the case of biosimilars. Slight differences in composition, even difficult to detect in pharmacological studies, may significantly affect the safety and efficacy of their use. That is why the European Medicines Agency (EMA) warns against treating biosimilar medicines as generics.
Replacing a biological drug with a biosimilar may not be safe
Patients treated with biological drugs fear that, without their knowledge, they may be "switched" to biosimilar drugs (see box). The hospital is to be economical, so it should buy cheaper drugs, and biosimilar drugs will be cheaper. Experts say that in these forms of therapy, choosing a drug only on the basis of its price is dangerous for patients, as it may be burdened with many unknown adverse reactions. Nobody disparages biosimilars, but with such a specific treatment regimen, it is necessary to maintain the consistency of the choice. It is important that the patient always starts the treatment with the same medicine. This means that if the treatment is started with the reference medicine, it should be completed with this one. And vice versa. If the patient is given drug X once and drug Y once, it is not known what he / she reacted badly to: the active substance or the additives. Unfortunately, the ministry probably does not take this into account, because it ignores the concerns of patients, at the same time explaining to them that there is no difference between a biological drug and a biosimilar drug, that these drugs are almost the same. Meanwhile, it almost makes a difference.
ImportantBiological versus biosimilar
A biological drug is a mixture of about a million protein substances (isoforms). The difficulties accompanying the manufacturing process are demonstrated by the fact that even the original biological medicine, produced at different time intervals, is not always a mixture of exactly the same proteins. How do I get out of it? In order for the drug to be useful in therapy, certain boundary parameters are established,which he must fulfill. It's like making tomato soup. In order for the soup to remain tomato soup, we all agree (we take boundary parameters) that we need soup vegetables, a piece of meat and tomatoes. However, no one specifies that a tomato will be real only if it is prepared with fresh tomatoes. So you can use a concentrate. And although we will eat tomato soup in both cases, its taste and ingredients will be different. Of course, with drugs, it's not about taste, but about therapeutic efficacy. We may not like the soup, but we won't get indigestion after it. In the case of drugs, it is different, because the occurrence of complications after the use of biological drugs is spread over time, and may become apparent even 96 months after the application of the therapy. Then it is not known whether the body has reacted to the active substance or to another component of the drug. Manufacturers of biosimilars try to adjust their products to the features specified in the registration processes for reference drugs. Will it always work? No one knows this. At present, it is not possible to say whether biological drugs or biosimilars are better.