Policies & Legislation
Nomenclature of biologicals and biocomparables in Mexico
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
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.
Lawsuits and US$450 million payout for price fixing and delayed generics entry
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.
FDA publishes final Q&A on biosimilar development and the BPCI Act
The US Food and Drug Administration (FDA) has published its final guidance document on questions and answers related to biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BCPI Act).
FDA voices concerns around drug patents and competition
On 10 September 2021, acting US Food and Drug Administration (FDA) commissioner Janet Woodcock, sent a letter to the US Patent and Trademark Office (PTO), outlining the agency’s concerns around drug patents and competition.
USA BIOSIM Act introduction
The Bolstering Innovative Option to Save Immediately on Medicines Act (BIOSIM Act) was introduced in the US on 22 April 2021. This hopes to encourage greater uptake and use of biosimilar therapies by increasing biosimilar reimbursement for healthcare providers in Medicare Part B [1].
