The demographic and epidemiological transitions are driving pharmaceutical expenditures up in Latin American and the Caribbean, with much of the cost falling on households. The domestic development and manufacturing of bio-similars could make medicines more affordable.

There is evidence of persistent inequalities in household financial protection of health and drugs spending in Latin America. Despite the expansion of coverage, strong inequalities persist in access to health and family spending on drugs in the region. Out-of-pocket spending in medicines is regressive in greater need for affordable medicines.

The global market for biologics and biosimilar pharmaceutical products is experiencing rapid expansion, primarily driven by the continuous discovery of new molecules. However, information regarding Latin America’s biological market remains limited.

Asia’s pharmaceutical sector has experienced remarkable growth over the last two decades, with companies in the region producing bulk of the world’s specialty generics, biologicals, and active pharmaceutical ingredients (APIs). The Asian pharma growth story has had several pillars for a strong and sustainable foundation that provided non-linear growth. This report introduces three models showing how Asian countries at different development stages — India, South Korea, and Singapore — have nurtured their own, self-sustaining pharmaceutical sectors.

This paper reviews the main pricing policies in Latin American countries, discussing their shortcomings. It also gives an overview of the most common pricing and reimbursement policies in Europe and describes in detail three well-established approaches — international price referencing, value-based pricing, including setting up of health technology assessment, and generic and biosimilar policies — building on country examples.

In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow.

We conducted a scoping review to map and critically examine the knowledge, perceptions and utilization of generics and biosimilars, among physicians, pharmacists, patients, the general population, and other stakeholders from LAC.

This paper will review the strategies and learning trajectories followed to tap the opportunities opened by the successive waves of biotechnologies: early imitators followed by late imitators in the first generation of biosimilars (erythropoietin, insulins, interferons), and then sequential entry and skipping stages during the second generation (monoclonal antibodies).

This paper aims to characterize the main actors in the Brazilian pharmaceutical industry — national companies, foreign companies and public laboratories — and analyze how they were affected and how they reacted to changes over the last 30 years in the institutional framework. The results show that national companies have been gaining prominence in the Brazilian pharmaceutical market with their internationalization movement and their strengthening of innovation strategies.

Cuba faces a dilemma between continuing its current portfolio of biotechnology drugs and vaccines with lower profitability or renewing its product portfolio with the associated costs and risks.

This study assesses Latin America and Caribbean countries’ capacity to innovate new pharmaceuticals, defined as developing new drugs and vaccines, repurposing existing drugs, and inventing around patents to produce new drug variations. Vaccine innovation includes reengineering existing vaccines, developing new manufacturing methods, and the clinical development of unapproved vaccine candidates initiated elsewhere.