Evgeni Tasovski, medical adviser in Actavis Bulgaria in an interview for FOCUS News Agency
FOCUS: It is expected that after the acquisition of Actavis from Watson to invest more in biosimilar products. What is a biosimilar product?
Evgeni Tasovski: First you need to say what a biological product is in general. This is a product that is made or biological products for human or replaces some of its biological hormones, enzymes, where there is a discrepancy.
Because they must be absolutely exact copy of human products is used genetic engineering technology, cell lines from different organisms, yeast and others. They are grown under special conditions - incubators. Ahead of putting in these cell lines it is implemented exactly matrix synthesis of the product we wanted. This may be insulin, erythropoietin, antibodies, etc. There are already many companies that have their own biotech laboratories.
When science develops, the most natural thing is to copy the most pressing hormones such as insulin, growth factor of pituitary, erythropoietin from the kidney to correct anemia, especially in renal failure and hemodialysis. The next thing science develops, explores and reaches a level, detects an antibody that blocks the development of a cell, the most common tumor, and thus to create some very valuable drugs that target is to heal incurable diseases that so far have been a scourge to mankind. This is a very valuable achievement. Those one who first makes the molecule, he put it on the market and is called biological molecule, organic produce, etc.
FOCUS: What happens then?
Evgeni Tasovski: When this product has a patent and it expires, and at the same time it has established itself in the market, it has established itself in the treatment of a disease or a substitute for therapy, another laboratory began to copy it. In this process, it may use the same cell line or another, but eventually gets the same product. Treatment is difficult to remove only the protein substance that is necessary to remove other unnecessary ingredients that often or immunized or dampen the main ingredient. This product has since been known as such antibody, is called biosimilar. Biosimilar product passes through many severe tests in severe clinical trials, etc. This product is not generic, it shouldn’t be considered as cheaper, poor copy. On the contrary - as it is done after a certain period of time, in many cases, certain shortcomings of the basic molecule of production of certain substrates, which remain in treatment, are eliminated. Many times these molecules called biosimilar are better than the first molecule that is detected. This often leads to a reduction in the price of the product and here is the chance of public funds to spend less money and be able to provide more people in need of such treatment with the product.
FOCUS: What time does the process of creating biosimilar product takes?
Evgeni Tasovski: It takes very long time, sometimes decades. First you should get the exact molecule; it is tested very precise, in specific ways. This is a long process and quite expensive - expensive, because they hit the new treatments, new technologies.
FOCUS :Specifically for cancer, are there any countries that successfully implement such products?
Evgeni Tasovski: All major countries apply such products. There are such target antibodies for the treatment of certain types of leukemia, certain types of myeloma. Absolutely successfully are achieved long remissions, and sometimes - a complete cure. 10-15 years is applied in all countries and the more civilized country, has more resources to be more easily implant the product on the market. We sometimes have to delay market entry, not so much from a regulatory standpoint, but because the market is less attractive. Large companies that create these products, look first to realize their production on large markets and they come on our market gradually, with some delay. We try Bulgarian patients not to be limited by legislative and other terms, the treatment for Bulgarian patients not to come with a huge delay. The market is small and not attractive enough and the companies themselves decide when to step on it.
FOCUS: How many authorized agents of this kind are there in Bulgaria?
Evgeni Tasovski: Over 50-60, maybe more. Because they are expensive products can hardly be realized with personal funds of the people. All try and prove their value and ratio benefit - price and fall in the positive list, then in the list of the National Health Insurance Fund they are being reimbursed. Oncology is reimbursed at 100%, diabetes, erythropoietins.
FOCUS: What products are available on the Bulgarian market?
Evgeni Tasovski: Most of the products are first product and the number of biosimilar is less. There is a misunderstanding that patients - once started with the first product when they receive the same product, but developed by another company occurs a resistance that the first product is best and the second is worse.
This is absolutely false, because it [the second product] may be better, to have fewer side effects. There must be understanding; the public fund must decide whether it can afford to keep paying expensive product, since there is the same at a lower price as persuading people not to develop fear of biosimilar. Rather, they must be satisfied that they can be treated with these products in Bulgaria.
FOCUS: Does Bulgaria produce biosimilar products?
Evgeni Tasovski:No. This is high-tech process. The plants are not large, but within the process itself is very complex. The most difficult is to find a stable cell line, it to be self-reproductive, etc. To implement within the genome of this cell line just genes that commanded the synthesis of insulin growth factor synthesis and then be removed to purify and filter the protein itself, because they are mostly proteins. This is not done yet in Bulgaria.
FOCUS: What will change after being approved the merger transaction with Watson?
Evgeni Tasovski: As a U.S. company, "Watson" will help with its organic products and they are much easier to be registered in Bulgaria, because they have a whole set of documents. That is the ability for rapid uptake of biosimilar products in the Bulgarian market through Actavis.
FOCUS:The price of biosimilar products is lower. Can you tell how many times it is lower?
Evgeni Tasovski: For each product it is individually, but there is a difference and it is not small. The cost of public funds is getting cheaper and thus more patients can be treated. If the market is very high, prices will drop further.
FOCUS: What kind of diseases can be applied biosimilar for?
Evgeni Tasovski: One of the first organic products is the insulin. Erythropoietin is produced by the human kidney and supports the production of red blood cells from bone marrow. There are several target antibodies for one type of leukemia, myeloma, etc. There are antibodies in the treatment of asthma. For this reason, the section that grew the most as an expense in the NHIF is the section for asthma because of these expensive drugs that entered on the market, not because the number of diseased people increased.