Every third woman and every fifth man in the world suffer from osteoporosis, warns the World Health Organization, and the number of patients in Serbia is constantly increasing. In order to contribute to the greater availability of biological therapy for these patients, Hemofarm is introducing its first biosimilara medicine specifically for patients suffering from osteoporosis.
In the Global Week of Biosimilars, the medicines which are expected to develop even faster in the future, it is important to point out that their importance is increasing in the therapy of many life-threatening or chronic diseases, for the treatment of which biological medicines are used. In Europe, there are more than 50 biosimilars, for 16 original biological medicines, currently approved and registered in the field of oncology, autoimmune disorders, rheumatology, diabetes, fertility. The first Hemofarm’s biosimilar is intended for osteoporosis patients.
‘A biosimilar is, as the name suggests, a medicinal product that is biologically similar to its original biological medicine. As every biological medicine is variable to a certain extent, it is impossible to develop an identical copy of the biological medicine. However, the biosimilar and its reference medicine are very similar and act without clinically significant differences in terms of quality, safety and efficiency’, says Dr. Danijela Stanišić Srdić, clinical pharmacology specialist and director of the Rx portfolio for the Western Balkans, Hemofarm - STADA.
In Serbia, biological medicines have a share of less than 10% in the total consumption of medicines. The reason is the extremely high price of biological therapy. Can we say that biosimilars are generic drugs?
'No. There is a significant difference. It takes 3 to 5 years on average to develop a generic drug, at a cost of 1 to 5 million dollars. However, to develop a biosimilar, it takes 7 to 8 years, at a cost of 100 to 250 million dollars. The production of biosimilars requires a high level of technological development and these medicines are developed through strict processes’, our interlocutor explains.
Biosimilars are available at a lower price than biological medicines. Why?
‘The development of a new biological medicine requires mandatory clinical trials, and it is known that they account for 70% of the costs and raise the price of the medicine many times over. Considering that a biosimilar is created according to the already existing biological medicine, the typical clinical trials are usually not required and therefore the final price of the medicine can be more affordable’, says Dr. Stanišić Srdić.
In the Global Biosimilars Week, the important news is that the patent protection for many biological medicines will soon expire, which will legally enable the production of their biosimilars, and which will make expensive biological therapy, by using new biosimilars, more accessible to a much larger number of patients who need it. Currently, more than 180 global pharmaceutical manufacturers are actively investing in the development and commercialization of biosimilars, which promises high-quality biological therapy at lower costs.
‘Biosimilars are beneficial for all participants in the healthcare system. Safe and affordable biological medicines become more available to patients, doctors get a wider choice of therapeutic options, and the health budget is relieved, as there is the option of redistributing funds’, our respondent points out.
Hemofarm’s first biosimilar
The first Hemofarm’s biosimilar is intended for the treatment of a widespread chronic disease, osteoporosis. It is the only medicine registered in Serbia for the treatment of osteoporosis that works by stimulating bone formation.
‘It is little known fact that in women over 45, osteoporosis causes more hospital days than diabetes, myocardial infarction and breast cancer. Data related to premature mortality and disability due to osteoporotic fractures are also alarming. The economic cost of treating osteoporosis in Europe, for example, in 2012 amounted to 37 billion euros, and 66% was spent on the treatment of incident fractures. That's why we at Hemofarm are proud to make modern biological therapy and our first biosimilar against osteoporosis more accessible to patients in Serbia’, says Dr. Danijela Stanišić Srdić from Hemofarm - STADA.
