BRICS countries will create a barrier-free regulatory regime for biosimilars
this HSE University BRICS Center for Competition Law and Policy (www.BRICSCompetition.org) The preliminary results of the annual analytical study on the introduction of biotech pharmaceuticals into the BRICS markets are summarized. One of the conclusions of the report is the need for large-scale sectoral studies on the removal of barriers to the pharmaceutical industry in the BRICS region. As a first step, it is recommended to focus on a relatively narrow but very promising topic – the development of the biologics market and the acceleration of the entry of biosimilars into the BRICS markets.
Biological drugs are synthesized from living cells (plasma, blood, etc.) using today’s most advanced biotechnology. They can cure the most serious and rare diseases. However, because the research and development of such drugs consumes a lot of resources, their prices are also the highest in the world. The cost of a single dose could exceed $3 million, the study said. Researchers say this creates obstacles for developing countries. Generic drugs of biological drugs are 70-90% cheaper than original drugs, and their efficacy is not inferior.
Experts estimate the potential of the biosimilars market to be at least US$100 billion by the end of this decade. Therefore, experts from the BRICS Pharmaceutical Market Competition Working Group call for the removal of regulatory barriers to the turnover of biopharmaceuticals and biosimilars in BRICS countries. The biologics market reflects many of the problems and contradictions in the BRICS pharmaceutical market. First, because this is a frontier area not only for BRICS countries, but also for the whole world; second, it involves acute issues such as innovative development, intellectual property rights, drug supply, external and internal competition, etc.
“At this stage, our goal is not to create a single market, our goal is to achieve healthy competition within the BRICS countries by removing barriers, mainly barriers to entry into the BRICS pharmaceutical market.” BRICS-wide projects can be approved through Bilateral and multilateral cooperation is carried out. Of course, there are legal and regulatory specificities and different requirements for standards, but these requirements should not become insurmountable obstacles, nor should they be used by countries solely for protectionist purposes. Within the BRICS, such unreasonable obstacles that do not conform to the logic of security or efficiency should be removed. ” Alexei Ivanov, Director of the BRICS Center for Competition Law and Policy.
It is important to recognize that competition authorities can have a significant impact not only on the protection of competition, but also on the reformulation and development of pharmaceutical markets. The BRICS countries do not have a common legal system, and experts point out that there is still much work to be done. The Working Group on the Pharmaceutical Market will hold its next meeting in Kazan in March 2025. Members of the Working Group plan to present the concept, structure, composition and timing of the sectoral study, which will help lay the foundation for the launch of a pilot project aimed at eliminating the regulatory barriers in the field. India may be one of the first countries to implement this pilot project.
By 2030, the global biosimilar market turnover will exceed $60 billion, and India has every opportunity to capture at least 10% of it. At present, the direction of biosimilars is actively developing, and 90 products have been registered in India, while only 45 have been registered in the United States – this is a very impressive number. Importantly, India is not alone in this and we see huge potential for collaboration in the biosimilars space in the BRICS space. In many areas, this kind of cooperation can reduce drug production costs by more than 90%, such as filgrastim, teriparatide, etc. ” emphasizes Samir Kulkarni, a professor at the School of Chemical Engineering, Mumbai, and a member of the centre’s research team.
Distributed by APO Group on behalf of the BRICS Center for Competition Law and Policy.
