The legal and regulatory framework for the development and approval of biosimilars in the European Union (EU) has pioneered the global initiatives on making biologic medicinal products a reality to many patients without threatening the sustainability of the health systems. The steps and requirements to be taken for the register of biosimilars in Portugal and in the EU will be addressed alongside highlighting the initiatives implemented to set the trust of prescribers and patients on biosimilars, the challenges still to face and luckily the existing and future opportunities to progress in this field.

The ICH guidelines for global biosimilar standards aim to harmonise regulatory approaches across regions, ensuring consistent evaluation and approval processes. These guidelines cover quality, safety, and efficacy requirements, focusing on the comparability of biosimilars to reference biologics. By standardising analytical techniques, clinical trial designs, and pharmacovigilance practices, the ICH guidelines help streamline biosimilar development, facilitate international collaboration, and enhance access to safe, effective, and high-quality biosimilar medicines worldwide.

Brazil faces challenges in local production of monoclonal antibodies, a critical area for healthcare. These challenges include technological limitations and complex regulatory processes, hindering domestic production. With a growing demand for these advanced therapies, Brazil seeks to overcome these obstacles through strategic partnerships and investment in research and development. This effort aims to strengthen local capabilities and ensure broader access to vital monoclonal antibody treatments.

Navigating the landscape of biosimilar licensing in Brazil requires a nuanced approach due to its intricate regulatory framework. Companies aiming for successful market entry must navigate approval processes, pricing negotiations, and local partnerships. Understanding these complexities and employing tailored strategies, such as leveraging data exclusivity periods and engaging with key stakeholders, can pave the way for a fruitful entry into Brazil’s biosimilar market.

The economic impacts of biosimilar adoption in Brazil are significant, with cost savings, improved access to treatments, and evolving market dynamics. The widespread use of biosimilars in the country’s healthcare system leads to substantial savings for patients and the healthcare industry. This trend also fosters competition among manufacturers, driving down prices and expanding accessibility to vital biologic therapies.

Unlike the PDP Program, which focuses on building national capacity through technology transfer from private companies, the PDIL aims to reduce the production and technological vulnerability of Brazil’s Unified Health System (SUS) by fostering local development of innovative solutions. the Ministry of Health would select projects regularly submitted to the Secretariat of Science, Technology, Innovation, and Health Complex (“SECTICS”), as well as projects submitted in response to public calls. Support would be formalized through any instruments aimed at promoting innovation. This initiative aims to bolster local production and technological development in Brazil’s healthcare sector, including the advancement of biosimilars.

The advances in access to biosimilars in Latin America, particularly in Brazil, are gradual and developing steadily. In the most relevant countries of the region, an increasing number of people are facing difficulties accessing medications. So, what is the next stage for Brazil in the new regulatory context?

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