Policies & Legislation
Nomenclature of biologicals and biosimilars in Peru
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
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
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
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
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 biosimilars in Argentina
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
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
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.
Australia introduces new bill to address drug shortages
Australia’s parliament has approved a new bill aimed at mitigating drug shortages in the country and ensuring that innovative medicines are accessible, available and affordable for all Australians.
Generic ‘skinny’ labelling under threat in the US
On 2 October 2021, GlaxoSmithKlein (GSK) was finally successful in challenging generics manufacturer Teva Pharmaceuticals (Teva) over its ‘skinny’ labelling of their beta blocker carvedilol, a generic version of Coreg.
