‘Fine-Tuning the Molecule’: Prospects for Biosimilar Market in BRICS Space

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The market for biological products and their analogues is one of the most promising in the pharmaceutical industry. BRICS countries currently have great opportunities to develop this segment. The International BRICS Competition Law and Policy Centre at HSE University, together with the Institute of Chemical Technology, Mumbai, held a meeting of the BRICS Working Group for the Research of Competition Issues in Pharmaceutical Markets.

The event was held as part of the BioPharma track of the international exhibition ChemTECH World Expo 2024, one of the largest industry exhibitions in Asia. The discussion was organised with the participation of Russia’s Federal Antimonopoly Service, which co-chairs the Working Group along with the State Administration for Market Regulation of the People's Republic of China (SAMR).

The meeting in Mumbai was a continuation of the discussion that began last December in Skolkovo. Previously, it was decided to conduct a comparative analysis of the rules for introducing biotechnological products to the BRICS market.

This time, scientists and representatives of regulatory authorities and pharmaceutical business from BRICS countries gathered to discuss ways to improve access to biological products and biosimilars in alliance countries.

© HSE University

Biologics are a class of medicinal products obtained from living cells (blood, plasma, etc.) using biotechnology. Today, this is the most promising and rapidly developing segment of pharmaceuticals. However, their price is colossal due to the high technological complexity of production and the high cost of research and development. These are the most expensive medicinal products in human history: one dose can cost 3.5 million USD. This price is unaffordable for most patients. Therefore, regulatory authorities—both in the US and EU, and in BRICS countries—are focused on the task of introducing to the market and increasing the availability of generic biologics—the so-called biosimilars. Most often, such a measure leads to a multiple reduction in cost and a multiple increase in the availability of innovative biological products.

Suresh Prabhu

The event was opened by Suresh Prabhu, Founding Chancellor of Rishihood University, an Indian politician and public figure, who previously headed the ministries of civil aviation, railways, commerce and industry of India. Earlier, he noted that the world market for biosimilars will exceed 60 billion USD in turnover by 2030 and India has every chance to take a share of at least 10% in it. At the same time, he emphasised the importance of the cooperation process in the niche of biosimilars in the BRICS space and noted the significance of the BRICS Centre initiative in this discussion.

‘BRICS countries have sufficient capacity to combine their manufacturing and R&D capabilities to ensure access to biosimilars for patients both in BRICS countries and beyond. The market for biosimilars is growing and can effectively compete with existing manufacturers of biological products,' said Samir Kulkarni, co-moderator of the discussion, professor at the Institute of Chemical Technology in Mumbai.

Alexey Ivanov

Director of the BRICS Centre, co-moderator of the event Alexey Ivanov spoke in regards to the research project, stating that the centre is working together with partners from India and other BRICS countries: ‘It is designed to develop ways to bring together the regulatory framework in BRICS countries in order to facilitate the access of biosimilars to markets and to assess the potential for creating the BRICS institutional platform that will facilitate joint research, development and production of biological products. A questionnaire for the pharmaceutical business was presented at the working group: the survey results will form the basis for the empirical part of the study.'

Timofey Nizhegorodtsev

Deputy Head of Russia's Federal Antimonopoly Service Timofey Nizhegorodtsev noted that 159 biotechnological products are currently registered in the Russian market. At that, biosimilars are registered for 38 international non-proprietary names, of which 30 are produced in Russia. Thus, Russia today is among the pioneers of the international biosimilar market.

‘It is necessary to change regulatory approaches to the development of biosimilars. It is clear that overburdened regulatory processes complicate and seriously increase the cost of producing biotechnological products and impede the timely launch of these products to the market. Optimisation of regulatory procedures is needed, but it is important to ensure consumer confidence in the quality, effectiveness, and safety of products,’ he emphasised.

The launch of biosimilars has already shown a multiple reduction in price. For example, the price of the original product Lenalidomide is 9,157 RUB, and the generic from the Indian manufacturer Hetero Labs costs only 350 RUB.

At the same time, it is important to find a balanced approach to pricing so that companies do not lose the incentive to engage in research and development, added Timofey Nizhegorodtsev.

‘If we lower regulatory barriers for biosimilars to enter the market, we must understand that we will face counter-criticism from international pharmaceutical holdings. These companies are already spreading rumours that medicines from BRICS countries are of poor quality, therefore, it is necessary to increase confidence in regulatory procedures while reducing barriers,' emphasised FAS Deputy Head.

Deputy Minister of Health of the Russian Federation, Sergey Glagolev, is confident that Russia needs more programmes for the development of biosimilars that meet the needs of Russian citizens, in particular, medicinal products in the sphere of oncology and orphan products.

Sergey Glagolev

‘We should explore the possibilities of localising the production of biosimilars in countries with similar problems, which will allow us to exchange experience in this matter. I highly support the overall work involving EAEU regulators in improving the guidelines for regulating biosimilars, which will allow greater reliance on preclinical and early clinical data, and more balance between development time and guarantees of its safety,’ he explained.

Huang Yuwei, Official at the Antimonopoly Enforcement Department I, State Administration of Market Regulation of the People’s Republic of China, spoke about the measures that SAMR is taking to protect competition in the pharmaceutical market and create a fair market environment for the innovative development of biosimilars.

In 2018, the biosimilar market size in China was approximately 1.6 billion RMB. It is expected to reach 52.2 billion RMB by 2028. In recent years, SAMR has continuously strengthened the regulation of pharmaceutical patents in an effort to ensure fair competition in the market and respect people's interests. According to Huang Yuwei, at the end of last year, methodological recommendations were developed to regulate the market of biosimilars, which are already showing their high efficiency.

‘Financial problems arose in the biotechnology market in the USA and Europe after the economic crisis,’ said Andrey Ivashchenko, Chairperson of the Board of Directors, ChemRar group of companies. Due to insufficient funding, many projects where new molecules are at the preclinical testing stage have been suspended. ‘This is a good chance for companies from BRICS countries that want to develop their own innovative molecules,’ he emphasised.

Other participants of the discussion were Vice Chancellor of the Institute of Chemical Technology Aniruddha Pandit, Vice Rector of the Sirius University of Science and Technology Roman Ivanov, Deputy Director of CUTS International Ujjwal Kumar, Director of HiMedia Laboratories Vishal Warke, Associate Professor of the MVP Samaj’s College of Pharmacy Mrudula Bele, and Coordinator of the Health, Intellectual Property and Biodiversity Programme at South Centre Vitor Ido.