BRICS Nations to Develop Unified Regulation for Biosimilar Products
Moscow – The HSE University BRICS Competition Law and Policy Centre (www.BRICSCompetition.org) has released an overview of the initial findings from its annual analytical research on the introduction of biotechnological drugs into the BRICS market.
One key takeaway from the report highlights the necessity of conducting an extensive sectoral analysis aimed at dismantling barriers within the pharmaceutical industry across the BRICS region.
As a preliminary measure, the focus is suggested to shift towards a more specific yet highly promising area – the development of the biologics market and the expedited entry of biosimilars into the BRICS markets.
Biological drugs are produced using living cells (plasma, blood, etc.) through cutting-edge biotechnology methods available today.
These drugs have the potential to cure severe and rare diseases. However, the immense resources required for their research and development lead to pricing that is among the highest globally.
The research indicates that the price for a single dose can exceed $3 million.
This situation, according to the researchers, presents significant barriers for developing nations.
In contrast, generics of biological drugs can be 70-90% cheaper than their original counterparts while maintaining comparable efficacy.
Experts project that the biosimilars market could reach at least $100 billion by the end of this decade.
As a result, members of the BRICS Working Group on Competition in Pharmaceutical Markets advocate for the removal of regulatory obstacles affecting the circulation of biological drugs and biosimilars within BRICS+ countries.
The biologics market encapsulates many issues and contradictions facing the pharmaceutical sectors within BRICS nations.
This is primarily due to its status as a cutting-edge field not only for BRICS countries but globally, addressing pressing concerns regarding innovative development, intellectual property, drug accessibility, and both external and internal competition.
‘At this stage, our objective is not to establish a unified market but to foster healthy competition within BRICS by eliminating barriers, especially those hindering entry into the pharmaceutical markets of BRICS member states,’
BRICS-wide initiatives can be developed through both bilateral and multilateral cooperation formats.
While there are indeed legal and regulatory differences, and varied standards, these should not pose insurmountable barriers nor be exploited for protectionist ends.
‘Within BRICS, we must dismantle unreasonable obstacles that are unfounded in security or efficiency logic,’ emphasizes Alexey Ivanov, Director of the BRICS Competition Law and Policy Centre.
It is crucial to understand that competition authorities can significantly influence the reform and evolution of the pharmaceutical market, extending beyond mere competition protection.
The BRICS nations currently lack a unified legal framework, and experts acknowledge that substantial work remains to be done.
Russian President Vladimir Putin has expressed the desire to foster a fair, just, and multipolar world.
At the next meeting of the Working Group on Pharmaceutical Markets, scheduled for March 2025 in Kazan, members plan to present a concept outlining the structure, composition, and timeline of a sectoral study aimed at laying the groundwork for a pilot project focused on removing regulatory impediments in this sector. India may emerge as one of the first countries to undertake this pilot project.
“The global biosimilars market is expected to exceed $60 billion in turnover by 2030, and India stands a strong chance of capturing at least a 10% share,” remarked 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 advancing, with 90 products already registered in India, compared to only 45 in the US – a remarkably significant achievement.
“It’s important to note that India does not operate in isolation; there is tremendous potential for collaboration within the BRICS framework concerning the biosimilars niche.
“In several domains, such partnerships could dramatically reduce pharmaceutical production costs by more than 90%, as evidenced by drugs like filgrastim and teriparatide,”