Founded in 2001, the association brings together the leading laboratories specializing in the manufacture and marketing of generic and biosimilar medicines, actively promoting access to healthcare for the Brazilian population.
On October 23, the Brazilian Association of Generic and Biosimilar Drug Manufacturers (PróGenéricos) celebrates 23 years of working to promote public health and access to quality medicines in Brazil. Since its founding, it has been a strong and active voice in the pharmaceutical sector and, above all, has positioned itself as committed to the Brazilian population by promoting generic and biosimilar drugs, ensuring effective alternatives that expand access to necessary treatments.
Operating on a non-profit basis, it liaises with various sectors of society and with public and private institutions, channeling the actions of its members, promoting and corroborating public debate on issues relevant to the health sector and the development of the pharmaceutical industry in Brazil.
According to Tiago de Moraes Vicente, CEO of PróGenéricos, PróGenéricos members account for approximately 90% of sales in the generic drug segment in Brazil.
“In recent years, our members have increased their share of the biosimilars market from 1.64% in 2021 to 9.72% in 2024, representing a 1,533% increase in unit sales,” he points out.
Areas of expertise
Intellectual Property
It plays an important role in preserving pharmaceutical patents and holds the right to exploit them for 20 years.
Regulatory Affairs
Since the enactment of Law No. 9,787/1999, which regulates generic drugs in Brazil, PróGenéricos has actively collaborated with the Brazilian Health Regulatory Agency (Anvisa) and other government agencies. In this way, it contributes not only to public consultations promoted by the Agency, but also with suggestions to improve and strengthen health policies that affect the pharmaceutical sector.
Biological Medicines
PróGenéricos is deeply committed to discussions on biosimilars, addressing critical issues such as the interchangeability of these products with pioneer (or reference) biologicals and the correct pricing, taking into account the investment and complexity involved. In addition, we collaborate in the evaluation and maintenance of patent terms for biological medicines that are strategic for the country, including those that are essential for the Unified Health System.
Our history over the years
1999: Creation of the National Health Surveillance Agency – Anvisa (Law No. 9,782) and enactment of the Generic Drugs Law (Law No. 9,787)
2000: Registration and start of marketing of the first generics
2001: Creation of PróGenéricos
2004: Launch of the Brazilian Popular Pharmacy Program by the federal government
2021: PróGenéricos begins to champion the cause of biosimilar medicines in Brazil
2023: PróGenéricos headquarters moves to Brasília (Federal District) and new management begins under the executive presidency of Tiago de Moraes Vicente.
2024: Celebration of the 25th anniversary of the Generic Drugs Law, with more than 2 billion units of generic drugs sold and savings of more than R$ 300 billion for the population.
Source: PróGenéricos/IQVIA
Benefits of Generic and Biosimilar Medicines
Expanded access to treatments: these medicines allow more people to access essential treatments for various health conditions without compromising therapeutic quality.
Cost reduction: they are sold at lower prices compared to pioneer drugs. This helps reduce costs for patients, public and private health systems, and health insurance plans.
Competition and innovation: stimulate competition among manufacturers, which can result in more competitive prices and incentives for continuous innovation. This may include improvements in manufacturing processes, development of new formulations, and the search for new therapeutic uses.
Quality and safety: They undergo rigorous regulatory approval processes to ensure that they are as safe and effective as reference products. This includes demonstrating equivalence in terms of quality, efficacy, and safety through comparative studies.
Access to advanced therapies: in the case of biosimilars, they represent an opportunity to access advanced biological therapies for the treatment of complex diseases such as cancer, autoimmune diseases, and other chronic conditions, for which only biological products were previously available at higher costs.
cc: ProGenerics