Moscow – The HSE University BRICS Competition Law and Policy Centre (www.BRICSCompetition.org) has published an overview of the preliminary findings from its annual analysis regarding the introduction of biotechnological drugs into the BRICS market.
A significant takeaway from the report emphasizes the need for comprehensive sectoral analysis to break down barriers within the pharmaceutical industry across the BRICS region.
As an initial step, it is recommended to focus on a more targeted yet promising area – the growth of the biologics market and the accelerated entry of biosimilars in BRICS markets.
Biological drugs are manufactured using living cells (plasma, blood, etc.) through advanced biotechnology techniques available today.
These medications have the potential to treat severe and rare diseases. Nevertheless, the substantial resources needed for their research and development result in prices that rank among the highest globally.
Research indicates that a single dose can cost over $3 million.
According to the researchers, this challenging scenario creates significant hurdles for developing nations.
Conversely, generics of biological drugs can be 70-90% lower in cost than their original counterparts while offering comparable efficacy.
Experts predict that the biosimilars market could surpass $100 billion by the end of this decade.
Consequently, members of the BRICS Working Group on Competition in Pharmaceutical Markets support the elimination of regulatory barriers affecting the distribution of biological drugs and biosimilars among BRICS+ countries.
The biologics market embodies several challenges and contradictions facing the pharmaceutical sectors within BRICS nations.
This is largely due to its nature as a cutting-edge field, not only for BRICS countries but globally, addressing urgent issues related to innovative development, intellectual property, drug accessibility, and both external and internal competition.
‘At this point, our goal isn’t to create a unified market, but rather to encourage healthy competition within BRICS by removing barriers, particularly those obstructing entry into the pharmaceutical markets of BRICS member states,’
Initiatives across BRICS can be formulated through both bilateral and multilateral cooperation frameworks.
While legal and regulatory differences exist, along with varied standards, these should not be insurmountable obstacles or exploited for protectionist purposes.
‘Within BRICS, we must eliminate unreasonable barriers that lack grounding in security or efficiency logic,’ underscores Alexey Ivanov, Director of the BRICS Competition Law and Policy Centre.
It is essential to recognize that competition authorities can play a pivotal role in the reform and development of the pharmaceutical market, extending beyond mere competition protection.
Currently, BRICS nations do not have a unified legal framework, and experts admit that considerable work is still needed.
Russian President Vladimir Putin has expressed a commitment to promoting a fair, just, and multipolar world.
At the upcoming meeting of the Working Group on Pharmaceutical Markets, slated for March 2025 in Kazan, members plan to introduce a concept outlining the framework, composition, and timeline for a sectoral study aimed at establishing a foundation for a pilot project focused on removing regulatory hindrances in this sector. India is expected to be one of the first nations to launch this pilot project.
“The global biosimilars market is anticipated to surpass $60 billion in turnover by 2030, and India has a strong opportunity to secure at least a 10% market share,” stated Samir Kulkarni, Professor at the Institute of Chemical Technology, Mumbai, and a member of the Centre’s research team.
“Currently, the biosimilar drug sector is rapidly progressing, with 90 products already registered in India, compared to only 45 in the United States – a remarkably significant achievement.
“It’s crucial to understand that India does not operate in isolation; there exists vast potential for collaboration within the BRICS framework concerning the biosimilars space.
“In various areas, such partnerships could dramatically lower pharmaceutical production costs by over 90%, as demonstrated by drugs like filgrastim and teriparatide,”
