Policies & Legislation

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.

FDA publishes final Q&A on biosimilar development and the BPCI Act

Home/Policies & Legislation | Posted 15/10/2021

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

Home/Policies & Legislation | Posted 08/10/2021

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

Home/Policies & Legislation | Posted 17/09/2021

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]. 

South Korea includes data exclusivity period for paediatric drugs approved abroad

Home/Policies & Legislation | Posted 10/09/2021

As of 5 May 2021, South Korea has updated the re-examination periods for post-marketing surveillance (PMS) of approved drugs. This now includes a four-year re-examination period for PMS that can now be granted for paediatric drugs approved based on both ‘domestic’ and ‘foreign’ clinical trials. 

MERCOSUR: new tariff for biological and biosimilar without Latin equity

Home/Policies & Legislation | Posted 03/09/2021

Within the pharmaceutical industry, the biosimilars business is growing and consolidating both internationally and locally. It is within this framework that MERCOSUR announced the new tariff to be implemented.

New trade agreement between Mexico, the US and Canada

Home/Policies & Legislation | Posted 27/08/2021

The new trade agreement between Mexico, the US and Canada, now called the T-MEC entered into force on 1 July 2020.