Moscow – The HSE University BRICS Competition Law and Policy Centre (www.BRICSCompetition.org) has published an overview of its initial findings from the annual analytical research concerning the introduction of biotechnological drugs into the BRICS market.

A significant point emphasized in the report is the importance of undertaking a comprehensive sectoral analysis to identify and eliminate barriers within the pharmaceutical industry throughout the BRICS region.

As a first step, the report suggests redirecting focus to a more targeted yet highly promising area – the development of the biologics market and the accelerated entry of biosimilars into BRICS markets.

Biological drugs are created using living cells (such as plasma and blood) through advanced biotechnology techniques available today.

These medications hold the potential to address severe and rare diseases. However, the substantial resources required for their research and development result in some of the highest prices worldwide.

The research finds that the cost for a single dose can soar beyond $3 million.

This scenario, according to the researchers, creates significant obstacles for developing countries.

In contrast, generics of biological drugs can be 70-90% cheaper than their original versions while maintaining similar effectiveness.

Experts anticipate that the biosimilars market could reach at least $100 billion by the end of this decade.

Consequently, members of the BRICS Working Group on Competition in Pharmaceutical Markets advocate for removing regulatory barriers affecting the circulation of biological drugs and biosimilars within BRICS+ nations.

The biologics market encompasses numerous challenges and contradictions affecting the pharmaceutical sectors within BRICS countries.

This is primarily due to its position as a cutting-edge field not just for BRICS nations but globally, addressing urgent issues related to innovative development, intellectual property, drug accessibility, and both internal and external competition.

‘At this stage, our aim is not to create a unified market but to promote healthy competition within BRICS by removing barriers, particularly those obstructing access to the pharmaceutical markets of BRICS member states,’

Initiatives across BRICS can be developed via both bilateral and multilateral cooperation formats.

While there are indeed legal and regulatory discrepancies, along with varied standards, these should not serve as insurmountable barriers nor be manipulated for protectionist purposes.

‘Within BRICS, we must eliminate unreasonable hurdles that lack a foundation in security or efficiency logic,’ underscores Alexey Ivanov, Director of the BRICS Competition Law and Policy Centre.

It is imperative to recognize that competition authorities can play a significant role in the reform and evolution of the pharmaceutical market, extending beyond mere competition protection.

The BRICS nations currently lack a cohesive legal framework, and experts acknowledge that considerable work is still needed.

Russian President Vladimir Putin has expressed a commitment to nurturing a fair, just, and multipolar world.

During the next meeting of the Working Group on Pharmaceutical Markets, scheduled for March 2025 in Kazan, members plan to present a concept that outlines the structure, composition, and timeline of a sectoral study aimed at paving the way for a pilot project centered on eliminating regulatory obstacles in this sector. India may become one of the first nations to initiate this pilot project.

“The global biosimilars market is projected to surpass $60 billion in turnover by 2030, and India has a solid opportunity to capture at least a 10% share,” noted 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 US – a remarkably notable achievement.

“It’s crucial to acknowledge that India does not operate in isolation; there exists tremendous potential for collaboration within the BRICS framework concerning the biosimilars niche.

“In several domains, such partnerships could significantly decrease pharmaceutical production costs by over 90%, as illustrated by drugs like filgrastim and teriparatide,”