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Biosimilars/General

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CVS’ Cordavis to launch Sandoz’s Hyrimoz (adalimumab)

Biosimilars/General | Posted 03/10/2023

In August 2023, CVS Health Corp announced it has launched a new company called Cordavis that will work directly with manufacturers to commercialize and co-produce biosimilar medicines for the US market.

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Coherus retracts AbbVie restraining order in Humira biosimilar dispute

Biosimilars/General | Posted 11/08/2023

Coherus BioSciences agreed to retract its restraining order against AbbVie in June 2023, an action taken to prevent AbbVie from terminating its Humira licence deal [1].

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Proposal to widen access to trastuzumab in New Zealand

Biosimilars/General | Posted 28/07/2023

In New Zealand there has been a proposal to widen access to intravenous trastuzumab from Herceptin to a biosimilar trastuzumab called Herzuma from 1 December 2023. 

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GADECCU position statement on biosimilars updated

Biosimilars/General | Posted 14/07/2023

GADECCU (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa), the Argentine Group for Crohn's Disease and Ulcerative Colitis, after providing key definitions on medical switch, non-medical switch and automatic substitution [1] and considering all the scientific information available, has updated its position in March 2023 regarding the use of biological medicines in clinical practice.

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GADECCU presents a new positioning on biosimilars

Biosimilars/General | Posted 13/06/2023

The Argentine Group for Crohn's Disease and Ulcerative Colitis (Grupo Argentino de Enfermedad de Crohn y Colitis Ulcerosa, GADECCU) has released an updated position statement on biosimilars, particularly regarding the alternate use of innovative biological drugs and biosimilars during the same chronic treatment in patients with inflammatory bowel disease.

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Biosimilars approved in the US

Biosimilars/General | Posted 14/08/2015

Last update: 19 May 2023

In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

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Biosimilars approved in Europe

Biosimilars/General | Posted 08/07/2011

Last update: 12 May 2023

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.

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Biosimilars approved in Canada

Biosimilars/General | Posted 31/01/2014

Last update: 17 February 2023

In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada.

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Joint statement on biosimilars in immune-mediated diseases in Spain

Biosimilars/General | Posted 30/05/2023

A study conducted and published by Monte-Boquet E et al. aimed to improve knowledge and use of biosimilar medicines in immune-mediated diseases, and to produce a unified framework for the use of biosimilars [1].

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An update on the joint EMA-HMA statement on interchangeability of biosimilar

Biosimilars/General | Posted 12/05/2023

On 21 April 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued an updated joint statement on the interchangeability of biosimilars approved in the EU.