DailySun
Moscow – The HSE University BRICS Competition Law and Policy Centre (www.BRICSCompetition.org) has published an overview of its initial discoveries from the annual analytical research concerning the market introduction of biotechnological drugs within the BRICS region.
A significant finding from the report underscores the importance of undertaking a comprehensive sectoral analysis aimed at breaking down barriers in the pharmaceutical industry throughout the BRICS area.
Initially, it is recommended to concentrate on a more specific yet promising aspect – the growth of the biologics market and the accelerated integration of biosimilars into the BRICS markets.
Biological drugs are synthesized using living cells (such as plasma and blood) through state-of-the-art biotechnological techniques available today.
These drugs hold the potential to treat severe and rare diseases. However, the substantial resources needed for their research and development contribute to some of the highest prices globally.
Research suggests that the cost for a single dose may surpass $3 million.
This scenario, according to the researchers, creates considerable challenges for developing nations.
Conversely, generics of biological drugs can be 70-90% less expensive than the originals while maintaining similar efficacy.
Experts predict that the biosimilars market could exceed $100 billion by the close of this decade.
Consequently, members of the BRICS Working Group on Competition in Pharmaceutical Markets call for the removal of regulatory barriers influencing the distribution of biological drugs and biosimilars among BRICS+ countries.
The biologics market embodies numerous issues and contradictions confronting the pharmaceutical industries within BRICS nations.
This is largely due to its nature as a cutting-edge domain, not just for BRICS countries but globally, addressing significant matters related to innovative development, intellectual property, drug accessibility, and both external and internal competition.
‘At this stage, our goal is not to create a unified market but to promote healthy competition within BRICS by eliminating barriers, especially those that obstruct entry into the pharmaceutical markets of BRICS member states,’
BRICS-wide initiatives can be fostered through both bilateral and multilateral cooperation formats.
While there are certainly legal and regulatory differentiations, alongside varying standards, these should not act as insurmountable hurdles or be leveraged for protectionist purposes.
‘Within BRICS, we must dismantle unreasonable obstacles that lack justification from a security or efficiency standpoint,’ emphasizes Alexey Ivanov, Director of the BRICS Competition Law and Policy Centre.
It’s crucial to recognize that competition authorities can play a pivotal role in the reform and progress of the pharmaceutical market, extending beyond mere competition enforcement.
The BRICS nations currently lack a consolidated legal framework, and experts concede that much work lies ahead.
Russian President Vladimir Putin has expressed ambitions to cultivate a fair, just, and multipolar world.
At the upcoming meeting of the Working Group on Pharmaceutical Markets, scheduled for March 2025 in Kazan, members plan to unveil a concept delineating the structure, composition, and timeline of a sectoral study designed to establish the groundwork for a pilot project aimed at eliminating regulatory barriers in this sector. India may emerge as one of the first nations to undertake this pilot project.
“The global biosimilars market is projected to exceed $60 billion in turnover by 2030, and India stands a strong chance of capturing at least a 10% 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 advancing rapidly, with 90 products already registered in India, compared to just 45 in the US – a significantly noteworthy accomplishment.
“It’s vital to highlight that India does not operate in isolation; there exists immense potential for collaboration within the BRICS framework regarding the biosimilars sector.
“In various domains, such collaborations could substantially reduce pharmaceutical production costs by over 90%, as evidenced by drugs like filgrastim and teriparatide,”
