BRICS countries will create a barrier-free regulatory regime for biosimilars

The HSE University BRICS Competition Law and Policy Centre (www.BRICSCompetition.org) has summarised the first results of its annual analytical study on bringing biotechnological drugs to the BRICS market. One of the conclusions of the report was the need to conduct a large-scale sectoral study on the removal of barriers in the pharmaceutical industry in the BRICS region. As a first step, it is proposed to focus on a relatively narrow but very promising topic – the development of biologics markets and accelerating the entry of biosimilars into the BRICS markets.

Biological drugs are synthesised from living cells (plasma, blood, etc.) using the most advanced biotechnology available today. They are capable of curing the most serious and rare diseases. However, since colossal resources are spent on research and development of such drugs, their prices are the highest in the world.  The cost of a single dose can exceed $3 million, the study says. This, according to the researchers, creates barriers for developing countries. Generics of biological drugs are 70-90% cheaper than original drugs and no less effective.

Experts estimate the potential of the biosimilars market at least $100 billion by the end of this decade. That is why experts of the BRICS Working Group on Competition in Pharmaceutical Markets call for the removal of barriers to the regulation of the turnover of biological drugs and biosimilars in the BRICS+ countries. The biologics market reflects many of the problems and contradictions of the BRICS pharmaceutical markets. Firstly, because this is a cutting-edge area not only for BRICS countries, but also for the whole world, and secondly, it touches upon the acute problems of innovative development, intellectual property, availability of drugs, external and internal competition.

‘At this stage, we do not aim to create a single market, our goal is healthy competition within BRICS through the removal of barriers, primarily barriers to entry into the pharmaceutical markets of the BRICS member countries. BRICS-wide projects can be developed through bilateral and multilateral formats of co-operation. Naturally, there are legal and regulatory peculiarities and different requirements to standards, but these requirements should not become an insurmountable obstacle and should not be used by countries for protectionist purposes only. Within BRICS, such unreasonable barriers that are not dictated by the logic of security or efficiency should be removed,’ explains Alexey Ivanov, Director of the BRICS Competition Law and Policy Centre.

It is important to realise that competition authorities can have a significant impact on pharmaceutical market reformulation and development, not just competition protection. The BRICS countries do not have a common legal regime and experts note that there is a lot of work to be done. By the next meeting of the Working Group on Pharmaceutical Markets, to be held in Kazan in March 2025, the Working Group members plan to present the concept, structure, composition and timing of a sectoral study that will help lay the groundwork for launching a pilot project to remove regulatory barriers in this area. India could be one of the first countries to implement the pilot project.

‘The global biosimilars market will exceed a turnover of $60 billion by 2030 and India has every chance to take a share of at least 10% in it. At the moment, the direction of biosimilar drugs is actively developing, 90 products have already been registered in India, while only 45 have been registered in the US – this is a very significant number. It is important that India is not alone in this, we see great potential for co-operation in the niche of biosimilars in the BRICS space. In a number of areas, such co-operation can reduce the cost of production of pharmaceuticals by more than 90%, such as, for example, filgrastim, teriparatide, etc.,’ emphasised Samir Kulkarni, Professor at the Institute of Chemical Technology, Mumbai, member of the Centre’s research team. 

Distributed by APO Group on behalf of BRICS Competition Law and Policy Centre.