FAS: IT IS NECESSARY TO REDUCE REGULATORY BURDENS IN DEVELOPMENT OF BIOTECHNOLOGICAL MEDICINES

Timofey Nizhegorodtsev, Deputy Head of the FAS Russia, spoke at a meeting of the BRICS Working Group for the Research of Competition Issues in the Pharmaceutical Markets in Mumbai (India)

Reports at the meeting were made by members of the Government of India, the Competition Authority of the People's Republic of China, scientists, as well as representatives of the world's leading pharmaceutical companies.

At the event, participants discussed ways to simplify access to biological medicines  and biosimilars in the BRICS countries. In addition, representatives of the countries of the association exchanged information on the current state of research, development and production of biological medicines, as well as on the level of availability in the biosimilar market.

As part of his speech, Timofey Nizhegorodtsev noted that biotechnological medicines are becoming a fast-growing class of therapeutic products. Thus, there are 159 such medicines registered in Russia, 7 new original molecules* were created directly in our country. The development and production of biotechnological medicines will contribute to increasing the level of accessibility of medicines for citizens. At the same time, this process is multi-stage and complex, it accounts for a significant part of health care costs. At the moment, there is a global trend towards simplifying regulatory requirements for their development, including in order to increase the competitiveness of medicines.

In this regard, the Authority primarily proposes to study the validity of current regulatory requirements and the impact of modern regulatory practices on the competitiveness of new biosimilar medicines. Then, proposals should be developed to reduce barriers to access of biological medicines to the BRICS markets, as well as to create unified regulatory instruments.

Reducing regulatory barriers is also a trend at the international level. According to the position of the World Health Organization, a comparative effectivness study may not be required if sufficient evidence of biosimilarity can be obtained from other stages of research.

Timofey Nizhegorodtsev stressed that the dissemination of best practices to reduce regulatory burdens will increase the safety and quality of biosimilars themselves, accelerate their entry into the market, contribute to an increase in production volumes by reducing the cost of licensing them and, as a result, create conditions for the development of competition in the pharmaceutical market.

Lian Huide, Director of the First Department of Antimonopoly Regulation of the State Administration for Market Regulation of China (SAMR), in turn, spoke about the measures that the authority is taking to protect competition in the pharmaceutical market. Thus, SAMR has conducted several antimonopoly investigations in the field of the development of active pharmaceutical ingredients. In addition, the authority is working to prevent patent abuse by pharmaceutical companies developing medicines. Lian Huide stressed that the antimonopoly authority is currently strengthening regulation in the field of pharmaceutical patents in order to ensure fair competition and respect for the interests of consumers.

Professor, Vice-Rector of the Institute of Chemical Technology of India Aniruddha Pandit also made a presentation at the event. He stressed the importance of sharing experience in regulating pharmaceutical markets by the BRICS countries and joining efforts to popularize the topic of biosimilars. Besides, Aniruddha Pandit noted that it is important to monitor the availability of medicines in pharmaceutical markets, as well as to constantly monitor their effectiveness and quality.

Following the meeting of the BRICS Working Group for the Research of Competition Issues in Pharmaceutical Markets, the parties agreed to continue exchanging information on the analysis of the validity of current regulatory barriers in the BRICS countries. In addition, participants of the meeting agreed to continue the discussion on the development of proposals to reduce regulatory barriers to the introduction of biologics into the pharmaceutical markets of the countries of the association.

Reference:

* Nurulimab+Progolimab, Sampeginterferon beta-1a, Divozilimab, Levilimab, Prolgolimab, Netakimab, Empegfilgrastim, BIOCAD developer

Biological medicinal products are medicines whose active substance is produced or formed out of a biological source and a combination of biological and physico-chemical methods is necessary to determine the properties and quality of which.

Biotechnological medicines’ production is carried out using biotechnological processes and methods.

Biosimilar medicines is medicines similar in parameters to a reference biological medicines.