Biocomparables approved in Mexico

Biosimilars/General | Posted 08/04/2022

In Mexico, biological products with expired patents are known as biocomparable biotechnology drugs (medicamentos biotecnológicos biocomparables). The regulatory body in charge of approving biocomparables is the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS).

Consortium of US hospitals to manufacture and sell biosimilar insulin

Biosimilars/General | Posted 01/04/2022

A consortium of large US hospitals, through the non-profit company Civica Rx, are to manufacture and sell biosimilar insulin capped at US$30 per vial.

Biosimilars approved in Argentina

Biosimilars/General | Posted 11/03/2022

In Argentina, the regulatory agency in charge of approving biological drugs is the National Administration of Drugs, Food and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT).

Key considerations when switching to biosimilar insulin

Biosimilars/General | Posted 04/03/2022

Biosimilar insulins can offer a cheaper alternative to originator insulators and substantial savings for healthcare systems. A recent ‘Quick guide: Initiating or switching to a biosimilar insulin’, [1] published in the Journal of Diabetes Nursing, outlines key aspects to consider when switching.

Nova Scotia, Canada implements biosimilar switching policy

Biosimilars/General | Posted 25/02/2022

Nova Scotia becomes the fifth Canadian province to implement a biosimilar switching policy, meaning that half of Canada’s provinces have now implemented such policies.

Amgen predicts a steady flow of biosimilar launches

Biosimilars/General | Posted 18/02/2022

Amgen CEO Robert Bradway predicted expanding the company’s biosimilars business with a steady flow of biosimilar launches at the J.P. Morgan Healthcare Conference, which was held on 11 January 2022.

Biosimilars approved in Colombia

Biosimilars/General | Posted 11/02/2022

In Colombia, the regulatory body for the approval of biologicals is the National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA).

Glossary of key terms

Biosimilars/General | Posted 26/10/2012

Last update: 9 June 2017

Confusion may sometimes surround terms used in the fields of generics and biosimilars. This has been recognized as a problem by EMA, who has expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the terms in the scientific literature and elsewhere [1].

Northwest Territories, Canada announces biosimilars switching policy

Biosimilars/General | Posted 04/02/2022

The Northwest Territories (NWT) has become the fifth jurisdiction in Canada to implement a biosimilars switching policy. The policy begins from 21 December 2021 and includes 10 biologicals.

Biosimilars approved in Ecuador

Biosimilars/General | Posted 28/01/2022

In Ecuador, the regulatory body for the approval of biologicals is the National Agency for Regulation, Control and Health Surveillance (ARCSA).