On June 17, Alexey Ivanov, Director of the International BRICS Competition Law and Policy Centre, moderated the moderated the strategic session entitled "Biologics and Biosimilars: Antitrust Aspect." The session was organized by the BRICS Centre together with BRICS+ partners as part of the research project that brings together researchers and pharmaceutical experts from various countries. The session participants included scientists, regulators and pharmaceutical industry representatives from BRICS+ countries. The aim of the meeting was to discuss ways to improve the accessibility of biologics and biosimilars for patients from BRICS+ countries and to review with pharmaceutical manufacturers the questionnaire to be filled in to populate the research project with empirical data.
The pharmaceutical industry occupies a special position in the global economy. Demographic factors are one of the fundamental drivers of growth in the global pharmaceutical market. According to the UN data, the world population will exceed 8 billion people by 2025, while life expectancy will also steadily increase. The growth of the global pharmaceutical industry is mainly driven by the growth of pharmaceutical markets in the BRICS+ countries. Today, the population of the BRICS+ countries exceeds half of the world's population.
As a consequence, the role and importance of cooperation between the BRICS+ member states in the field of pharmaceuticals, especially in the production and sale of biologics, is increasing. The market of biological drugs and their analogs is one of the most promising in the pharmaceutical industry. Now the BRICS+ countries have great opportunities for the development of this segment. Due to the complexity of the molecular structure of biological drugs, their development and production are very expensive, which leads to high prices for drugs for end patients. Moreover, biologic drugs are usually covered by several process patents in addition to the patent on the drug itself. Generics of biologic drugs, so-called biosimilars, enter the market with additional challenges, including regulatory hurdles and inadequate intellectual property and competition protection laws that limit access to these drugs. In addition, patents for biologics are usually held by large Western manufacturers, which use various anti-competitive practices to protect their positions in the relevant product market.
Questionnaire
The International BRICS Competition Law and Policy Centre is conducting a survey of BRICS pharmaceutical industry representatives to assess the presence or absence of barriers to entry in the BRICS market for manufacturers of biologics and biosimilars.
The focus is on assessing the set of factors and potentially harmful anti-competitive practices that negatively affect the availability of biologics and biosimilars to consumers in the BRICS countries. The results of the survey will be summarized in the Centre's study.
If you are a pharmaceutical manufacturer, we invite you to fill in the questionnaire.