Policies & Legislation

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.

Australia introduces new bill to address drug shortages

Home/Policies & Legislation | Posted 28/01/2022

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

Home/Policies & Legislation | Posted 05/11/2021

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.

Lawsuits and US$450 million payout for price fixing and delayed generics entry

Home/Policies & Legislation | Posted 29/10/2021

In late September 2021, Gilead Sciences, Teva and Bristol Myers Squibb, were sued by US pharmacy chains related to delayed launch of HIV generics. In early October 2021, three generics drugs companies, Taro Pharmaceuticals USA, Novartis’ Sandoz and Apotex agreed to pay almost US$450 million to resolve alleged claims that they illegally collaborated on price, supply and allocation of numerous medications.