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Hemofarm's first biosimilar
Hemofarm dedicated its first biosimilar to patients with osteoporosis, thus trying to contribute to greater availability of biological therapy for these patients. The World Health Organization warns that every third woman in the world, as well as every fifth man, suffers from osteoporosis, while in Serbia the number of these patients is constantly increasing.

Biosimilars, which are still expected to develop in the future, are used in the therapy of a large number of life-threatening or chronic diseases, for the treatment of which biological drugs are used. More than 50 biosimilars are currently approved and registered in Europe, for 16 original biological drugs, in the field of oncology, autoimmune disorders, rheumatology, diabetes, fertility….

‘A biosimilar, as its name suggests, is a biologically similar drug to its original biological drug. Since each biological drug is to some extent variable, it is impossible to develop an identical copy of a biological drug. However, biosimilar and its reference drug are very similar and work without clinically significant differences in terms of quality, safety and efficacy’, Bojana Podgorac Milenković, manager of the Rx marketing business unit in Hemofarm said.

In Serbia, biological drugs have a share of less than ten percent in the total consumption of drugs. The reason is the extremely high cost of biological therapy. Can we say that biosimilars are generic drugs?

‘No, we can’t. There is a significant difference. It takes an average of 3 to 5 years to develop a generic drug, at a cost of 1 to 5 million dollars. It takes 7 to 8 years to develop a biosimilar, at a cost of 100 to 250 million dollars. The production of biosimilars requires a high level of technological development and these drugs are developed through rigorous processes’, Podgorac Milenković explained.

Biosimilars are available at a lower price than a biological drug. Why?

‘The development of a new biological medicine requires mandatory clinical trials, and it is known that they account for 70 percent of the total costs and multiply the price of the medicine. Since the biosimilar is created according to an already existing biological drug, clinical trials are not necessary and therefore the final price does not have to be high’, Bojana Podgorac Milenković, Master of Pharmacy - Medical Biochemist added.

In the world, patent protection for a large number of biological drugs will soon expire, which will legally enable the production of biosimilars. Slightly more than 180 drug manufacturers, globally, are actively investing in the development and commercialization of biosimilars, which promises high-quality biological therapy at lower costs.

‘Biosimilars bring benefits to all participants in the health care system. Safe and cost-efficient biological drugs are becoming more accessible to patients, doctors are getting a wider choice of therapeutic options, and the health budget is relieved and the possibility of redistribution of funds is available,’ Podgorac Milenković said.

Hemofarm’s first biosimilar

Hemofarm dedicated its first biosimilar to the treatment of a widespread chronic disease - osteoporosis. It is the only drug registered in Serbia for the treatment of osteoporosis that has effect on stimulation of bone formation.

‘Little is known that in women older than 45, osteoporosis causes more hospital days than diabetes, myocardial infarction and breast cancer. Data related to premature mortality and disability due to osteoporotic fractures is also alarming. The economic cost of treating osteoporosis in Europe amounted to EUR 37 billion in 2010, whereof 66 percent was spent on treating incidental fractures. That is why we at Hemofarm are proud that we can make modern biological therapy more accessible to patients in Serbia’, Bojana Podgorac Milenković said.