On March 12, in Kazan (Russia) the BRICS Working Group on Pharmaceutical Markets Competition Research held a meeting entitled: “Ensuring access to biosimilars for developing countries.” The event was held within the framework of the international round table “Development of Competition in Pharmaceutical Markets” at the Educational and Methodological Center of the FAS Russia.
Problems of the pharmaceutical industry, such as the use of compulsory licenses, pricing of medicines and ensuring access to them, are becoming more and more relevant for the countries of the global South, including the BRICS countries. Recently, the Working Group has focused on bringing biosimilars to market, which significantly reduce the price of advanced biotech drugs, providing access to modern treatments for people in developing countries.
As part of a joint research project, the BRICS Competition Centre and BRICS+ partners are conducting a comparative analysis of the rules for bringing biotech drugs to the BRICS+ market. The Centre's experts have developed questionnaires for manufacturers and antitrust regulators.
“We have already received meaningful feedback from competition authorities and are at the stage of analyzing these responses. A more complete conclusion will be presented later this month,”
said Alexey Ivanov, Director of the BRICS Competition Law and Policy Centre, who moderated the session.
The biologics market generates total revenue of about $500 billion and is expected to reach about $1.5 trillion by 2035, said Samir Kulkarni, Professor at Mumbai Institute of Chemical Technology. Unlike chemicals, biotech drugs are developed using living cells that are cultured to produce targeted biological molecules, making the process of creating them much more complex and expensive. This also affects the price of original drugs of this category. Thus, the cost of treatment with monoclonal antibodies can reach $100 thousand per year, which makes it unaffordable for most patients. Biosimilars, in turn, can reduce the price of these drugs by 90-95%, while ensuring similar efficacy.
Samir Kulkarni's report was devoted to the biosimilars regulatory requirements. It is important that drugs in this category meet strict requirements, including similarity of amino acid sequences, molecular structure and biological activity. This requires sophisticated analytical instrumentation and rigorous testing at all stages of development. In addition, the safety and efficacy of biosimilars in preclinical and clinical trials, including assessment of toxicity, immunogenicity and the length of time the drug remains in the body, must be considered. There is an ongoing debate about whether both the molecule and final form of a drug need to be evaluated to confirm its biosimilarity.
“Some experts, including myself, believe that assessing the stability of the final product is sufficient for this purpose, rather than considering all the structural characteristics of the drug. This issue requires further scientific discussion,”
emphasized the speaker.
The first results of a study on the rules for bringing biotech drugs to the BRICS+ market from Indian partners were presented by Murdula Bele, Professor at MVP Samaj College of Pharmacy. According to preliminary findings, large companies with more than 500 R&D employees tend to have higher market penetration. Brazil proved to be the most favorable market for Indian companies despite a more stringent regulatory environment, while China, South Africa and Russia faced challenges due to different regulatory frameworks and patent restrictions. The study concludes that efforts to improve R&D efficiency, regulatory harmonization and market access can accelerate market entry of affordable biologics in the BRICS countries, ultimately benefiting access to healthcare globally.
Continuing the theme, Vitor Henrique Pinto Ido, Associated professor University of Sao Paulo, delivered a report on the key challenges of ensuring access to biotech drugs in the BRICS countries. These included regulatory barriers, restrictive practices by intellectual property rights holders, and insufficient antitrust enforcement. He called for a review of the existing regulatory system to accelerate the approval of biotech, including mutual recognition among BRICS+ countries. In addition, there is a need to integrate competition authorities into regulatory biotech approval processes and develop a joint database between BRICS+ countries.
“The introduction of biosimilars for bevacizumab and trastuzumab in Russia led to significant price reductions and increased patient access. The average price paid by the Russian state for these antibodies fell by over 50-60% within two years of local biosimilar competition. This resulted in a doubling of the number of patients treated,”
emphasized the speaker.
The convergence of approaches of the BRICS countries to the development and registration of medicines, including biosimilars, will eliminate administrative barriers, facilitate the entry of new companies into pharmaceutical markets and make these markets more competitive, agreed Andrey Tsyganov, Deputy Head of the FAS of Russia. He noted that the pharmaceutical industry in the BRICS countries demonstrates a significant level of development. In India, pharmaceuticals account for about 3% of GDP, in China — almost 2.5%, in Brazil — more than 1.5%, in Iran — 1.2%, including the production of antibiotics and drugs for the treatment of cancer.
At the moment, 159 biotech drugs are registered in Russia, with biosimilars registered for 41 INN (international nonproprietary names), of which 33 INNs are produced in Russia, said Timofey Nizhegorodtsev, Deputy Head of the FAS Russia. It is crucial to ensure non-discriminatory access to clinical trials throughout the BRICS space, he is convinced.
“Reducing regulatory barriers is a global trend. WHO believes that a comparative efficacy study [of an original biological drug and a biosimilar] may not be necessary if sufficient evidence of biosimilarity can be obtained from other stages of research,”
said Mr. Nizhegorodtsev.
At the end of the meeting, Vladimir Andrianov, Director for Partner Relations at R-Pharm, once again stressed the need to harmonize registration requirements when bringing drugs to international markets, and also drew attention to the problem of intellectual property in the context of scientific developments that may be of interest to manufacturers. In addition, it is necessary to develop the production of original biotechnological drugs, Andrianov is convinced.
“Biosimilars are a good track for honing interaction and understanding. But I would like to see this story spread to original drugs development in the future.”
he concluded.
The event was attended by representatives of antitrust authorities of BRICS+ countries, heads of pharmaceutical companies, as well as experts from leading BRICS universities. The BRICS Working Group for the Research of Competition Issues in Pharmaceutical Markets is co-chaired by the FAS of Russia and the State Administration for Market Regulation of the People's Republic of China.
