Policies & Legislation

Regulatory Certainty Strategy for biosimilars launched in Mexico

Home/Policies & Legislation | Posted 09/04/2024

In February 2024, Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) announced the ‘Estrategia de Certidumbre Regulatoria’ – Regulatory Certainty Strategy (RCS) – for biosimilars.

Strategic plans of ANVISA and COFEPRIS to advance health regulation

Home/Policies & Legislation | Posted 11/03/2024

ANVISA and COFEPRIS, Brazilian and Mexican health regulatory agencies respectively, unveil strategic plans for 2024-2027. ANVISA prioritizes World Health Organization (WHO) recognition, identification of medicinal products (IDMP) standards adoption, and biosimilar drug development. COFEPRIS focuses on regulatory certainty, digitalization, and aligning with global manufacturing standards.

Panama enacts new bill to guarantees the supply of medicines

Home/Policies & Legislation | Posted 29/02/2024

On 18 January 2024, the National Assembly (AN-Panamanian Parliament) approved in the third debate Bill 1007, which regulates medicines, supplies, devices, and other products for human health, their public acquisition, and other provisions were enacted.

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'.

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.

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.

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).

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.

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.

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.

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.

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.’

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.

AMLAC: regulatory agency for medicines in Latin America and the Caribbean established

Home/Policies & Legislation | Posted 13/06/2023

AMLAC, a regional body for Latin America and the Caribbean, is being set-up to promote greater access to safe, effective medical equipment and medicines through a combination of regional regulations.

Pros and cons of tenders for generics and biosimilars

Home/Policies & Legislation | Posted 06/06/2023

An editorial entitled ‘Tenders for Generics and Biosimilars: A Challenging Purchasing Policy’ has been published in the European Journal of Health Economics [1]. It is authored by Fernando Antoñanzas, Carmelo Juárez-Castelló, and Roberto Rodríguez-Ibeas from the University of Rioja in Spain and discusses the challenges associated with the implementation of tendering processes for generics and biosimilars in healthcare purchasing policies.

Medicare drug price negotiation: what next?

Home/Policies & Legislation | Posted 30/05/2023

A commentary published in Value in Health by Dr Sean D Sullivan of the University of Washington School of Pharmacy offers insights into Medicare drug price negotiation [1]. The commentary discusses the implications of negotiation [2] and asks the question, ‘what next?’

Medicare drug price negotiation: implications

Home/Policies & Legislation | Posted 04/05/2023

In 2022, The Inflation Reduction Act (IRA) was signed into law in the US. This sets out to empower the US Secretary of Health and Human Services (HHS) to develop and implement methods and a process to negotiate a limited number of prescription drug prices in the Medicare programme directly with manufacturers [1]. A commentary by Dr Sean D Sullivan of the University of Washington School of Pharmacy, published in Value in Health, offers insights into the implications of Medicare drug price negotiation [2].

New guidance for Medicare Drug Price Negotiation Program

Home/Policies & Legislation | Posted 20/04/2023

The Centers for Medicare and Medicaid Services (CMS) released a memorandum that acts as a new guidance for the Medicare Drug Price Negotiation Program [1].

FDA and FTC join forces to promote competition in the biological market

Home/Policies & Legislation | Posted 14/04/2023

The Federal Trade Commission (FTC) and the US Food Drug Administration (FDA) are collaborating to promote market competition for biological drugs, including biosimilars and interchangeable biosimilars, which will help increase access to safe, effective and affordable treatments for patients.

EU and Latin America/Caribbean launch virtual marketplace for pharmaceuticals

Home/Policies & Legislation | Posted 31/03/2023

Under the Global Gateway umbrella, the EU and Latin America and the Caribbean (EU-LAC) are partnering on health resilience and vaccine production, and as part of this effort, they organized a high-level pharma forum and matchmaking event – the European Union - Latin America and Caribbean Summit – from February to April 2023.

Generics and biosimilars Initiative

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