Policies & Legislation

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.

The effects of regulation on innovation in Mexican pharmaceutical industry

Home/Policies & Legislation | Posted 09/03/2023

This article analysed the effect of regulation on the innovation processes in the pharmaceutical industry. The research was exploratory in nature and the design used was a case study, corresponding to the development of a new medication for treating diabetes by a Mexican pharmaceutical company [1].

FDA publishes BsUFA III research roadmap

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

In early 2023, the United States Food and Drug Administration (FDA) published their Biosimilar User Fee Act (BsUFA) III research roadmap [1] as part of their regulatory research pilot programme [2].

The US Biologics Competition Act and Biosimilar Red Tape Elimination Act

Home/Policies & Legislation | Posted 27/01/2023

The US introduced the Biologics Competition Act of 2022 (HR 887) in September 2022. This was followed by the introduction of the Biosimilar Red Tape Elimination Act in November 2022. Both acts seek to make biosimilar products more accessible and increase their uptake in the US.

EU public consultation on revised framework for compulsory licensing of patents

Home/Policies & Legislation | Posted 25/11/2022

The European Commission had opened a public consultation on ‘Intellectual property (IP) – revised framework for compulsory licensing of patents’. This was opened from 7 July 2022 to 29 September 2022.

Canada upholds decision to approve biosimilars where reference product is not marketed

Home/Policies & Legislation | Posted 30/09/2022

In court proceedings that concluded in August 2022, the Canadian Federal Court dismissed applications for judicial review put forward by AbbVie regarding the approval and marketing authorization of JAMP Pharma's Simlandi (adalimumab) product [1]. This confirms that Notice of Compliance (NOC) regulations do not apply to biosimilars when reference products are not marketed in Canada.

PDUFA VI: FDA could promote generics competition

Home/Policies & Legislation | Posted 29/07/2022

In the US, the current Prescription Drug User Fee Act (PDUFA) is due to expire in September 2022. A recent report calls for the new iteration of the act (VI) to increase Food and Drug Administration’s (FDA) authority to promote generic competition [1].

House bill passes FDA funding fees but conflicts with Senate bill

Home/Policies & Legislation | Posted 15/07/2022

In the Unites States (US), the House of Representatives voted to pass legislation to reauthorize the fees that help fund the US Food and Drug Administration (FDA). However, there are some conflicts between the House and parallel Senate bill that need to be overcome before either can be passed.

US Senate clarifies status of interchangeable biosimilar exclusivity

Home/Policies & Legislation | Posted 27/05/2022

The United States (US) Senate Health, Education, Labor and Pensions (HELP) Committee released a draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA) on 17 May 2022.

Nomenclature of biologicals and biosimilars in Peru

Home/Policies & Legislation | Posted 20/05/2022

This article, the last in a series on the nomenclature of biological and biosimilar medicines in various Latin American countries based on the study by Iglesias Galiano M in 2021, analyses the management and implementation of the nomenclature of biological and biosimilar medicines in Peru [1].

United States legislation to improve access to insulin

Home/Policies & Legislation | Posted 29/04/2022

In the US, a bill was passed in late March 2022 to cap the monthly cost of insulin at US$35 for insured patients. In addition, in early April 2022, a bipartisan bill to reform the US Food and Drug Administration (FDA) review and approval process for complex generics/biosimilars was passed.

Generics and biosimilars Initiative

News

Research

General