Over the past two decades, biological medicines have transformed the treatment of chronic and complex diseases such as cancer, rheumatoid arthritis, and diabetes. However, the high cost of these therapies has limited access for millions of patients worldwide, placing pressure on public and private healthcare systems.
In this context, biosimilars – medicines that are highly comparable to a reference biologic, with demonstrated efficacy and safety – have emerged as one of the most strategic pillars of pharmaceutical innovation.
The global biosimilars landscape
According to the International Generic and Biosimilar Medicines Association (IGBA), the economic potential of biosimilars is significant: between 2021 and 2025, cumulative global savings could reach USD 285 billion, a direct result of introducing competition into the biologics market and the consequent reduction in prices.
Beyond the financial impact, the use of biosimilars has allowed governments to reinvest resources in expanding healthcare coverage, infrastructure, and access to innovative therapies, creating a multiplier effect that extends well beyond immediate cost savings.
The European landscape illustrates this impact clearly. According to the IQVIA report The Impact of Biosimilar Competition in Europe 2024, published in January 2025, the introduction of biosimilars generated cumulative savings of EUR 56 billion by mid-2024, while also providing an additional 6.9 billion days of patient treatment.
As more biologics lose patent exclusivity, the role of biosimilars becomes even more central. For the global pharmaceutical industry, they represent not only an economic opportunity but also a strategic imperative: to ensure equitable access to cutting-edge therapies while sustaining innovation models that balance science, the market, and public health.
The challenge of equity in access to biological therapies
Despite scientific advances and the global expansion of the pharmaceutical market, equitable access to biological therapies remains a major challenge.
According to estimates from the World Health Organization (WHO), approximately half of the world’s population still lacks access to essential medicines, and this deficit is even more critical in the case of biologics.
The main barrier lies in the high cost of reference biological medicines, driven by complex manufacturing processes, high R&D investments, and long periods of patent exclusivity. In this context, biosimilars play a transformative role: by introducing effective competition into the biologics market, they reduce treatment costs, improve supply predictability, and enable more patients to be treated within the same public or private budget.
The IGBA notes that beyond generating direct savings, the adoption of biosimilars enables structural reinvestments, such as hiring healthcare professionals, modernizing laboratories, and funding innovative therapies.
Patent expirations and portfolio expansion
The global biosimilars market is entering a new phase of expansion, driven by the expiration of patents for biologics with high economic and therapeutic impact. According to IQVIA (2025), between 2024 and 2030, 69 biological medicines will lose exclusivity in Europe, almost twice the number recorded in the previous seven years.
This trend represents a strategic window for the pharmaceutical industry, opening opportunities both for companies already operating in the biosimilars segment and for new entrants. Although some of these molecules have limited commercial value (annual sales below EUR 500 million), eight biologics with revenues exceeding EUR 1 billion will also enter direct competition by the end of the decade, representing a combined market potential of EUR 25 billion in annual sales before their patents expire.
Furthermore, a growing trend of regulatory harmonization is being observed between the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). This is particularly relevant for sponsors seeking global launches in a landscape that demands companies with regulatory robustness and multilevel technical capabilities, such as Synvia, whose advanced analytical infrastructure, international regulatory experience, and integrated clinical execution are key differentiators.
Biosimilars studies: complexity and technical differentiation
Clinical studies involving biosimilars require a level of rigor and sophistication significantly higher than that of conventional bioequivalence studies.
While both aim to demonstrate product comparability, biosimilars involve complex biological molecules whose three-dimensional structure and manufacturing processes demand detailed analyses and multiple clinical and laboratory endpoints.
Among the main differentiators are pharmacokinetic (PK) and pharmacodynamic (PD) parameters. The PK endpoint assesses how the body absorbs, distributes, and eliminates the drug, while the PD endpoint measures the biological effect produced, such as changes observed in specific biomarkers.
In parallel, PK analysis requires the support of specialized analytical infrastructures equipped with high-precision instruments such as LC-MS/MS platforms, and quality control systems that ensure full traceability and audit readiness.
Beyond the technical aspects, biosimilars studies involve complex strategic and regulatory planning, including the selection of suitable comparators, the design of representative sample populations, and compliance with harmonized international standards.
Synvia and its expertise in comparative biological studies
With 20 years of experience and more than 1,600 studies conducted, Synvia has established itself as the leading clinical research organization in Latin America. This trajectory has enabled the company to develop an operational model capable of meeting the highest international regulatory standards, providing the pharmaceutical industry with a comprehensive and integrated platform for conducting clinical studies.
Currently, Synvia carries out comparative studies between reference biological products and biosimilars, combining the specialized expertise of its Feasibility and Regulatory Affairs teams. The former is responsible for defining study design, establishing PK and PD protocols, determining volunteer numbers, inclusion criteria, and technical timelines. The regulatory team, in turn, ensures alignment with the requirements of agencies such as ANVISA, EMA, and FDA.
Synvia also stands out for its high-level analytical and laboratory infrastructure. Its analytical facilities, with more than 30 LC-MS/MS systems (the largest in Latin America) conduct studies with a high degree of precision and traceability, while its in-house central laboratory is equipped for high-complexity analyses, including immunological and biochemical assays such as ELISA.
Another strategic advantage is Synvia’s ability to operate across multiple therapeutic areas, expanding partnership potential with different sponsors. The company is prepared to conduct biosimilar studies in oncology, immunology, metabolism, and emerging fields such as weight management drugs, whose patents are set to expire soon, driving a new generation of biological studies.
Brazil as a competitive destination for biosimilar studies
Brazil combines factors that make it a highly competitive destination: favorable cost-benefit ratio, population diversity, and regulatory reliability.
ANVISA plays a central role in this context. Aligned with international reference agencies such as the EMA and FDA, the Brazilian agency adopts harmonized guidelines for the development and approval of biosimilars.
Another differentiating factor is Brazil’s diverse population profile, which offers significant statistical and scientific advantages, especially in studies evaluating interindividual variability and immunogenicity. This diversity, along with the growing participation of the population in clinical research programs, strengthens the country’s position as a strategic partner in international projects.
Finally, Brazil offers competitive costs compared to North American and European markets while maintaining high ethical and quality standards. With its experience and fully integrated service chain, Synvia is one of the main drivers of this evolution, connecting Brazil´s scientific potential with the global demands of the pharmaceutical industry.
The future of biosimilars
Biosimilars are reshaping the global pharmaceutical industry landscape. They represent a bridge between innovation and sustainability, allowing scientific progress to reach a greater number of patients without compromising the economic viability of healthcare systems.
International experience demonstrates that the impact of biosimilars goes far beyond immediate savings: when properly implemented, they generate structural efficiency, strengthen competition, and create budgetary space for investment in new technologies. At the same time, they require a mature ecosystem with regulatory support, transparent communication on safety and efficacy, and a network of scientific partners capable of ensuring quality and traceability at every stage of the process.
Boost your biosimilar projects with Synvia. Talk to one of our specialists: comercial.farma@synvia.com