Policies & Legislation

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.