The session continued the research project of the BRICS Centre and BRICS+ partners, which includes a comparative analysis of the rules for bringing biotech drugs to the BRICS+ market, Alexey Ivanov noted. The decision to conduct the study was made in December 2023 at the meeting of the BRICS Working Group for the Research of Competition Issues in Pharmaceutical Markets. In March 2024, the BRICS Centre together with the Institute of Chemical Technology (ICT) Mumbai continued the discussion during the next meeting of the Working Group.
Biologic drugs are a relatively new type of medication that can significantly improve the lives of people with diseases that have been poorly treated in the past. These include cancer, endocrine, autoimmune and other diseases. However, due to the complexity of the molecular structure of biologic drugs, they are very expensive to develop and produce, resulting in high drug prices for patients.
The solution may be generics of biological drugs, so-called biosimilars, which can reduce the prices of innovative drugs by 70-90%. Now the BRICS+ countries have great opportunities to develop this segment of drugs, said Samir Kulkarni, Professor at the Institute of Chemical Technology, Mumbai (India).
"The biosimilars market is expected to reach $100 billion by 2030. I believe the figure will be much higher, as the market will start to expand with the increased availability of biosimilars,"
noted the professor.
There is a need for broader cooperation within BRICS to build a joint support ecosystem to provide researchers and developers with the necessary materials, from ampoules and syringes to medical gloves. Another critical task is to harmonize regulatory procedures to make it easier to bring biosimilars to market.
"If there is a unified regulatory framework within BRICS+, manufacturers will not have to adjust to different requirements in different countries. Perhaps doing away with unnecessary regulatory rules or a single window approach will really facilitate bringing these products to the markets faster,"
said Samir Kulkarni.
As part of a joint research project with the BRICS Centre, questionnaires were sent to drug manufacturers and pharmaceutical and antitrust regulators in BRICS countries to assess the range of factors and potentially harmful anticompetitive practices that limit access to these medicines. Mrudula Bele, M.V.P. Samaj's College of Pharmacy, said that according to company responses, the average time it takes for regulators to approve or reject biosimilar applications in India is between a year and two years However, in other BRICS countries, this timeframe is much longer. In addition, 41% of companies surveyed believe that regulatory processes are more stringent than required to ensure the quality, safety and efficacy of biosimilars. The questionnaire survey of manufacturers and regulators is ongoing. The ultimate goal of the project is to develop certain proposals in the form of a policy document that will be useful to governments or health departments of BRICS countries to improve access to biosimilars, the speaker emphasized.
Vilena Galkina, GR Director, Geropharm, spoke about the problems faced by Russian producers of biosimilars. Among them are low awareness of such drugs among doctors and patients, as well as the use of "evergreen" patents by large pharmaceutical companies. Such patents are obtained by pharmaceutical companies after the expiration of the basic registration, making minor changes in the composition or dosage of the drug. This makes it difficult or impossible to promptly launch generic drugs on the Russian market.
By the end of this year, the BRICS Centre will prepare a report that will cover all issues related to regulatory barriers, promotion of BRICS cooperation, patent aspects and competition.
"In the section on patents, we will focus on the barriers that exist in some countries and how these barriers have been overcome, for example, in India,"
Alexey Ivanov noted.
Denis Vinokurov, Director for Business Development and Communications of ChemRar Group, believes that one of the steps to strengthen cooperation could be the creation of a BRICS healthcare fund. The member countries of the association will be able to conduct joint clinical trials to reduce costs and accelerate the launch of innovative drugs on the BRICS markets.
"ChemRar has the largest collection of small molecules for commercial use in the world - more than 1,700,000 small molecules. If we have such a treasure, why don't we in the BRICS countries think about creating a center for cooperation at the early stage of drug development?"
Vinokurov said.
Vsevolod Letsko, Head of External Communications, Generium, also supported the proposal, emphasizing that the company's portfolio includes high-tech drugs for the treatment of orphan diseases and that Generium is ready to share its experience with colleagues.
BRICS countries need to help each other in terms of creating unified patent approaches and developing common procedures for regulating the development of biosimilars, conducting research, registration, examination, quality control and, possibly, pricing, said Vadim Kalinichenko, Representative of the Department for Regulation of Medicines and Medical Devices of the Russian Ministry of Health. "We also propose to consider in the joint development of biosimilar drugs the possibility of localizing production in those countries involved in this development," he added.
Building trust in biosimilars is a pro-competitive measure and will require serious development of tools to communicate and educate all stakeholders: doctors, pharmacies, patient groups, said Ujjwal Kumar, Associate Director of CUTS International. However, a very careful distinction should be made between biosimilars and biomimics (localized copies of biologics that have received approval without following international standards for evaluation and approval of biosimilars).
"If we don't distinguish between the two, we may fail in communication because biomimics can be distrustful,"
cautioned Ujjwal Kumar.
Concluding the discussion, Alexey Ivanov emphasized how difficult it is to create a proper coordination mechanism in the health sector within the BRICS due to differences in regulatory rules. At the moment, it seems reasonable to create a pilot project focused on the advanced technology sector, which requires a new type of regulation, but is also very sensitive from a social point of view.
"We have already discussed this with Deputy Minister of Health Sergey Glagolev. We think that linking our proposal to create a BRICS platform for the development of biosimilars with the recently established Association of BRICS Health Ministers will be a win-win solution for us,"
Ivanov said.
The International BRICS Competition Law and Policy Centre is conducting a survey of the BRICS pharmaceutical industry to assess the presence or absence of barriers to entry in the BRICS market for manufacturers of biologics and biosimilars.
The results of the survey will be summarized in the Center's study.
If you are a pharmaceutical manufacturer, we invite you to fill in the questionnaire.
