Policies & Legislation
Nomenclature of biologicals and biocomparables in Mexico
Following the articles on the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil and Argentina based on the study by Iglesias Galiano M. 2021, this article will provide a summary of the same in Mexico.
EMA concept paper towards a tailored clinical approach in biosimilar development
In November 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) published a 'Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development'.
Public consultation for the modification of the biosimilars regulation in Brazil
The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) initiated a public consultation on expediting regulation of biosimilar drugs. The goal is to decrease dependence on high-cost imported biological medicines and position Brazil as a significant regional exporter of lower-cost biological therapies.
COFEPRIS promotes regulatory cooperation in the Americas
During the 60th Executive Council of the Pan American Health Organization (PAHO) held in Washington, DC, USA, on 25–28 September 2023, Alejandro Svarch Pérez, Head of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), on behalf of the Mexican government, emphasized the need to strengthen healthcare systems based on primary care.
CMS proposes allowing Part D plans to switch biologicals to non-interchangeable biosimilars
On 6 November 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) proposed a new rule to give Medicare Part D plans more flexibility. It has been proposed that biosimilars can now be substituted for the reference biologicals, even if these have not been deemed interchangeable by the US Food and Drug Administration (FDA).
ANVISA's decision on 'Skinny labels' for generics pending
The Brazilian health regulatory agency, ANVISA (Agência Nacional de Vigilância Sanitária), is still considering whether to allow generic drug labelling to omit indications of the originator product that are still under patent.
More drugmakers sue over IRA yet one withdraws
In the United States, Boehringer and Novartis join other drugmakers [1] in suing the US government over drug price negotiations in the Inflation Reduction Act (IRA). However, Japan-based Astellas Pharma withdrew its lawsuit filed against the US government in early September 2023.
First drugs for Medicare price negotiation selected
The US Department for Health and Human Security (HSS) has selected the first drugs for Medicare price negotiation.
Updated Biosimilar Red Tape Elimination Act introduced by Senator Lee
US Republican Senator for Utah, Mike Lee, has introduced an updated ‘Biosimilar Red Tape Elimination Act.’
Inflation Reduction Act explained
The US Assistant Secretary for Planning and Evaluation’s (ASPE) ‘Medicare Part B drugs: trends in spending and utilization 2008-2021’ was published in June 2023 [1]. This outlines aspects of the Inflation Reduction Act (IRA) which is designed to address the rapid rate of increase in Part B drug spending and lower costs for Medicare enrollees.
