Clinical research on biologics has become increasingly relevant on the global stage, with a growing focus on biosimilars — biological medicines that are highly similar to already approved reference biological products. These medicines offer the promise of expanding access to innovative treatments, reducing costs for health systems and increasing competitiveness in the pharmaceutical market. In Brazil, this area is expanding, driven by new government policies such as the Productive Development Partnership Program (PDP) and the Drug Industry Development Program (PDIL).
Source: Analysis Group
The Importance of Biosimilars
Biosimilars are considered a natural evolution of biological medicines, which are more complex and costly to develop than conventional medicines. The importance of biosimilars lies in their ability to offer more affordable alternatives to original biological medicines, while maintaining the same efficacy and safety. This is particularly crucial in a country like Brazil, where access to cutting-edge medicines can be limited by economic and infrastructure issues.
According to an article published in JAMA Oncology , the development and approval of biosimilars have shown promise in reducing costs and increasing access to treatments in several therapeutic areas, including oncology. This is especially relevant in a context of growing demand for treatments for complex and chronic diseases.
The Growth of Biosimilars in Brazil
Brazil has made significant progress in regulating and registering biosimilars. According to ANVISA, the registration of biosimilars in the country has grown consistently, approaching the numbers observed in Europe, one of the most mature markets for these drugs. This evolution reflects both the country's regulatory capacity and the growing interest of the pharmaceutical industry in developing and commercializing biosimilars in the Brazilian market.
A report by Sindusfarma highlights that, by the end of 2022, Brazil had seen a considerable increase in the number of approved biosimilars, which demonstrates the maturity of the sector and the opening of the market for these products. With the growth in the number of registrations, clinical research in Brazil is also expected to gain more momentum, attracting investments and new studies that can validate and expand the use of biosimilars in the country.
Expectations for the PDP and PDIL Programs
The expectation that more clinical trials of biologics and biosimilars will take place in Brazil is directly linked to recent federal government initiatives, such as the Partnerships Program for Productive Development (PDP) and the Local Development and Innovation Program (PDIL). These programs aim to encourage local production of medicines, which should boost clinical trials in the country, strengthening the national industry and expanding the population's access to innovative treatments.
PDPs, in particular, aim to promote technology transfer between foreign and domestic companies, enabling Brazil to become a hub for the development and production of biologics. This initiative can boost clinical research in Brazil, attracting international studies and promoting the development of new biosimilars in the country.
The PDIL, in turn, focuses on modernizing the national pharmaceutical industry, with incentives and support for investments in innovation and research. With this, it is expected that Brazil will not only increase its production capacity for biosimilars, but also become a reference center for development, leading to more clinical studies in the area.
This week I was at an event promoted by Jack Leckerman, Global Human Interaction , moderating a panel precisely about access to these therapies.
The event itself was very productive, with 2 days of discussions on the topic and a lot of emphasis on how to use the incredible training presented by the various participants, national and international companies, through incentive programs.
It was a rich opportunity for exchanges, especially regarding the topic of PDILs .
Conclusion
Clinical research on biologics, especially biosimilars, is experiencing great expectations and growth in Brazil. The increase in biosimilar registrations and new government policies, such as the PDP and PDIL, signal a promising future for the development of this sector in the country. With more clinical research being conducted locally, Brazil has the opportunity to consolidate itself as an important global player in the development of biologics, benefiting both the industry and the population.
Biosimilars are not just a promise of more affordable treatments; they represent a significant step forward in democratizing access to healthcare. With adequate support from public policies and continued investment in clinical research, Brazil will be able to fully leverage this potential, contributing to innovation and the sustainability of the healthcare system.
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