In their review, Machado and colleagues examine the transparency and regulatory guidelines pertaining to the licensing of biosimilars, as well as the count of biosimilars granted approval by 13 medicines regulatory authorities .
In a review by Machado et.al., the authors examine the transparency and guidelines for biosimilars licensing and the number of biosimilars approved by 13 medicines regulatory authorities. In this context, we focused the discussion on seven Latin American countries: Argentina, Brazil, Chile, Colombia, Guatemala, Mexico and Peru as part of the broader review .
In the dynamic landscape of Latin America's pharmaceutical industry, Argentina stands out with its distinctive structure and policies that have shaped its biopharmaceutical sector. Over the course of this century, the biopharmaceutical industry in Argentina has emerged as a critical player in the country's healthcare sector.
Biosimilars are an essential element of sustainable healthcare systems, with significant potential contribution to competitive markets. However, there are still challenges to be faced; for instance, there is a growing trend of biosimilar development targeting a limited range of biologicals .
The rate of uptake of biosimilars has accelerated as stakeholders have become increasingly comfortable with these products . However, the adoption of biosimilars is lower in regions experiencing low social and governmental trust [2, 3].
Biosimilars are now key players in the global drugs market offering potentially more affordable treatment options with similar safety and efficacy. However, there are concerns about non-medical switching practices of originator biologicals/biosimilars in different regions. A webinar was held on 20 July 2022 to discuss non-medical switching practices and to explore the importance of safeguarding the physician–patient relationship .
During the Biosimilars Medicines Conference in May 2023, Mr Aurelio Arias from IQVIA delivered a presentation about the biosimilar void in Europe. He highlighted that while the uptake of biosimilars has accelerated, there is a growing disparity in market concentration for smaller biologicals .
In Brazil, the approach of the Industrial Economic Complex of Health (Complexo Econômico-Industrial da Saúde, CEIS) has been adopted in the planning of policies related to the health economy. This involves the integration of health, industrial and innovative policies.
The biopharmaceutical industries in Latin American countries have gained significant attention in recent years, with an important growth in Argentina and Brazil where the policies implemented have emphasized collaboration between the public and private sector.
The market for copy biologicals in China has significantly grown over the past decade. The government has been actively promoting the development and use of copy biologicals as a way to improve access to affordable health care. As a result, the number of pharmaceutical companies developing copy biologicals has also increased rapidly and is expected to continue to grow in the coming years.