Policies & Legislation

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 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.

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.

Use of generic drugs is promoted in Peru

Home/Policies & Legislation | Posted 23/07/2021

To promote the use of generic medicines in Peru, on 31 October 2019, the Executive Branch published regulations through Supreme Decree No. 026-2019-SA, which established mechanisms to ensure access to lower-cost medicines. The decree recognizes the need to adopt measures that favour the population’s access to essential medicines, biological products, and medical devices.

A new dawn for China’s patent law

Home/Policies & Legislation | Posted 16/07/2021

China has made changes to its patent law which were enacted on 1 June 2021. The revisions mean China’s new patent law system resembles the US Hatch-Waxman approach and include a patent linkage system and patent term extensions.

Affordable Care Act to stand in USA

Home/Policies & Legislation | Posted 09/07/2021

On 17 June 2021, the US Supreme Court ruled to uphold the Affordable Care Act (ACA) and Obamacare. This ensures the current pathway for biosimilars to reach the US market will be maintained which will provide access to cheaper versions of expensive biological therapies.

Proposals for the commercialisation of generics move forward in Chile

Home/Policies & Legislation | Posted 02/07/2021

The project known as the Medicines Law 2, led by a Joint Commission, seeks to settle discrepancies between senators and deputies regarding the sale of bioequivalent and generic medicines in Chile. The project, which is in its third stage, amends the Health Code to regulate generic drugs in order to prevent the vertical integration of pharmaceutical companies and pharmacies. In this way, it seeks to solve some pending issues left by the current drug legislation.

Generics and biosimilars Initiative

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