Policies & Legislation

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.

Nomenclature of biologicals and biosimilars in Chile

Home/Policies & Legislation | Posted 22/04/2022

Continuing with the series of articles on the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil, Argentina, Mexico and Colombia, based on the publication of an extensive study carried out in Peru by Iglesias Galiano M in 2021, this article will provide a summary focused on Chile [1].

Nomenclature of biologicals and biosimilars in Colombia

Home/Policies & Legislation | Posted 08/04/2022

This article analyses the realities of Colombia as part as a broader study carried out by Iglesias Galiano M, focused on some reference countries as well as those countries of the region with level IV according to Pan American Health Organization (PAHO) classification, which have implemented guidelines for the authorization of biotechnological and biosimilar medicines in relation to the management of the nomenclature.

FDA funds regulatory science pilot for biosimilars

Home/Policies & Legislation | Posted 25/03/2022

The US Food and Drug Administration (FDA) has announced US$5 million funding for research proposals under the Biosimilar User Fee Act (BsUFA III) Regulatory Science Pilot Program.

Nomenclature of biologicals and biocomparables in Mexico

Home/Policies & Legislation | Posted 18/03/2022

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.

Nomenclature of biologicals and biosimilars in Argentina

Home/Policies & Legislation | Posted 11/03/2022

Author Maritza Iglesias Galiano of the Universidad Peruana Cayetano Heredia in Lima, Peru conducted a study in 2021 on the management and implementation of the nomenclature of biological and biosimilar medicines in Argentina, information of which are being summarized below.

Ireland’s new generics and biosimilars framework agreement

Home/Policies & Legislation | Posted 04/03/2022

In December 2021, Medicines for Ireland (MFI) signed a new framework agreement on the supply and pricing of non-originator, generic, biosimilar and hybrid medicines to be implemented between 2021‒2025.

Nomenclature of biologicals and biosimilars in Brazil

Home/Policies & Legislation | Posted 25/02/2022

This article addresses with the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil, the study of which was carried out in 2021 by Maritza Iglesias Galiano of the Universidad Peruana Cayetano Heredia in Lima, Peru.