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Policies & Legislation

Concept Paper V13G05

EMA concept paper towards a tailored clinical approach in biosimilar development

Home/Policies & Legislation | Posted 09/02/2024

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'. 

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Public consultation for the modification of the biosimilars regulation in Brazil

Home/Policies & Legislation | Posted 16/01/2024

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.

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COFEPRIS promotes regulatory cooperation in the Americas

Home/Policies & Legislation | Posted 12/12/2023

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.

Switching V19A17

CMS proposes allowing Part D plans to switch biologicals to non-interchangeable biosimilars

Home/Policies & Legislation | Posted 21/11/2023

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).

Labelling V14I26

ANVISA's decision on 'Skinny labels' for generics pending

Home/Policies & Legislation | Posted 14/11/2023

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.

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Advances in the availability of innovative medicines in Mexico

Home/Policies & Legislation | Posted 31/10/2023

A legal modification has recently been achieved for the faster recognition and release of innovative medicines on the Mexican market.

Law V13C29

More drugmakers sue over IRA yet one withdraws

Home/Policies & Legislation | Posted 10/10/2023

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.

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First drugs for Medicare price negotiation selected

Home/Policies & Legislation | Posted 22/09/2023

The US Department for Health and Human Security (HSS) has selected the first drugs for Medicare price negotiation.

Interchangeability V18K30

Updated Biosimilar Red Tape Elimination Act introduced by Senator Lee

Home/Policies & Legislation | Posted 25/08/2023

US Republican Senator for Utah, Mike Lee, has introduced an updated ‘Biosimilar Red Tape Elimination Act.’

Regulation V13H16

Inflation Reduction Act explained

Home/Policies & Legislation | Posted 24/07/2023

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.