The Fifth Eurasian Pharmaceutical Summit in Tashkent was devoted to discussing the key issues related to ensuring access of biosimilars to the market of the Eurasian Economic Union (EAEU) countries.

During the panel discussion on this theme, the CEO of STADA in Uzbekistan, the head of the cluster “Uzbekistan and Kyrgyzstan” Bakhtiyar Khadjimuhamedov shared his opinion.

In the coming years, patents for many biotechnological drugs that treat complex oncological and endocrinological diseases will expire. This opens the way for the appearance on the market of many of their analogs – generics and biosimilars. In particular, biosimilars are biotechnological drugs similar to the original drug produced for the first time and submitted for registration after the patent expiration of the original drug.

Biosimilars have long been popular in Europe. For example, in Slovakia, with a population of 5.5 million people, the market for these drugs reaches 1.8 billion euros, and in Bulgaria, with 6.5 million residents, it exceeds 2 billion euros.

The expert noted that in Uzbekistan and Kyrgyzstan, the market for bioproducts, particularly biosimilars, is significantly lagging behind. At the same time, manufacturers focus on several key factors: market capacity, readiness of the healthcare system, flexibility of regulatory issues, and legal aspects, such as the expiration of patent protection.

According to the speaker, biosimilars can provide significant economic benefits for countries with limited healthcare budgets. In Uzbekistan, with a population of 37 million people and an average life expectancy of about 74 years, demand for biopreparations is expected to increase. The incidence rate is increasing, and the need for treatment is growing, which increases the importance of affordable and high-quality biosimilars.

STADA is developing in this direction – recently, a registration certificate was received for the first biosimilar in Uzbekistan. However, there are logistical and regulatory nuances regarding the import of products manufactured before obtaining a registration certificate. In this regard, examples of the successful simplification of regulatory procedures in European countries allowed for the rapid and high-quality introduction of biosimilars to the market.

In conclusion of his speech, Mr. Khadjimuhamedov called on manufacturers, regulators, and industry specialists to actively cooperate to ensure patients’ access to the necessary drugs. STADA plans to actively develop educational programs for medical workers to improve their qualifications and readiness to use bioproducts.

The speaker expressed hope that successful negotiations and dialogue will help overcome existing barriers and open up new opportunities for introducing biosimilars in the markets of the EAEU countries.

Alpomish Mashrabkhanov, UzA