Decoding US IRA and Medicare drug price negotiations

Home/Reports | Posted 25/06/2024

The Alliance for Safe Biologic Medicines (ASBM) in collaboration with the Generics and Biosimilars Initiative (GaBI) held a webinar on the 2022 Inflation Reduction Act (IRA), on 26 July 2023. An outline of this webinar, ‘Medicare drug price negotiations: impact on healthcare development and patient access to medicines’, was published in GaBI Journal [1].

Highlights of EMA approvals in 2023 focus on cancer medicines

Home/Reports | Posted 14/05/2024

In its ‘2023 Human Medicines Highlights’, the European Medicines Agency (EMA) provided a comprehensive overview of key recommendations for the approval of medicines in various therapeutic areas. Notably, the report highlighted significant advancements in cancer treatment approvals, including cancer biosimilar.

Follow-on biological/ biosimilar approvals in Latin America by therapeutic class

Home/Reports | Posted 03/04/2024

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

Home/Reports | Posted 27/03/2024

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].

Biosimilars in cancer treatment in Europe and the US

Home/Reports | Posted 07/03/2024

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

Home/Reports | Posted 16/01/2024

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

Home/Reports | Posted 05/12/2023

In a review by Machado, 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

Home/Reports | Posted 31/10/2023

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

Home/Reports | Posted 22/09/2023

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

Home/Reports | Posted 08/09/2023

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].