Reports
Follow-on biological/ biosimilar approvals in Latin America by therapeutic class
According to a review by Machado et al., across seven Latin American nations, biosimilar approval patterns diverge from Canada, Europe, and the US. Anti-anaemic and diabetes treatments are notably lacking approvals, while Brazil emerges as a leader in biosimilar authorization [1].
Follow-on biological/ biosimilar approvals landscape in Latin America
Machado et al. analyse the clarity and regulatory guidelines associated with the approval process for biosimilars. Additionally, they examine the quantity of biosimilars that have received approval from 13 different medicines regulatory authorities in their review [1].
Benefits of innovative biologicals and biosimilars for patients and health systems
A report carried out by several authors showed that if the launch of biotechnological drugs unleashed controversy at the time due to their novelty, those of biosimilars were even greater. Fifteen years after the launch of the first biosimilar and taking into account current regulations, the question remains as to whether they represent opportunities or risks in terms of safety, effectiveness and costs for patients, physicians and health systems. The challenges are to educate and communicate in a broad and sustained manner about scientific innovation in pharmaco-biology, the value of innovators, and the evidence of effectiveness and safety of biosimilars [1].
Biosimilars in cancer treatment in Europe and the US
The World Health Organization's (WHO) most recent projections suggest a staggering 77% surge in new cancer cases globally by 2050, compared to the approximate 20 million recorded in 2022. As a result, the anticipated number of cancer-related deaths worldwide is poised to double to around 18.5 million by 2050, in contrast to the 9.7 million reported in 2022. Alarmingly, numerous countries still lack sufficient resources allocated to treatment and care services.
First approvals of similar biotherapeutics in seven Latin American countries
In their review, Machado et al. 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 [1].
Biosimilar terminology: insights from seven Latin American countries
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 [1].
Biopharmaceutical industry in Argentina in the 21st century
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.
Emerging disparities in market concentration among biosimilars
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 [1].
Biosimilars uptake rates in Europe and the UK
The rate of uptake of biosimilars has accelerated as stakeholders have become increasingly comfortable with these products [1]. However, the adoption of biosimilars is lower in regions experiencing low social and governmental trust [2, 3].
Guidelines for biosimilars around the world
Biosimilar guidelines and regulations are being developed all over the world, as outlined by Huiguo Hu at the Biosimilars Europe Congress [1].
