Biosimilars/General

US PBMs add multiple Humira biosimilars to formularies

Biosimilars/General | Posted 03/02/2023

In the US it has been announced that several pharmacy benefit managers (PBMs) will be adding multiple biosimilar versions of AbbVie’s Humira (adalimumab) to their formularies in 2023.

Canada’s Ontario introduces biosimilars switching policy

Biosimilars/General | Posted 20/01/2023

The Canadian province of Ontario is the latest to introduce a biosimilars switching policy. Under the terms of the policy, Ontario Drug Benefit (ODB) recipients who are on an originator biological will be required to transition to a Health Canada approved biosimilar version of the drug.

Key facts of biosimilars approval regulation in Brazil

Biosimilars/General | Posted 18/11/2022

This article provides a brief overview of the important aspects and an update on the regulatory pathways for approval of biological products in Brazil [1].

Canada’s Saskatchewan province introduces biosimilars switching policy

Biosimilars/General | Posted 04/11/2022

The Canadian province of Saskatchewan is the latest to introduce a biosimilars switching policy. As of October 2022, the province joins British Columbia (BC) [1], Quebec [2], Alberta, Ontario [3], New Brunswick [4], Nova Scotia [5], and the Northwest Territories [6] in introducing biosimilars switching policies.

A Canadian gastro-enterologist’s view on advising on biosimilars

Biosimilars/General | Posted 28/10/2022

Acting as a ‘trusted advisor’ when answering questions about biological and biosimilar products is important for Canadian physician, Dr Dustin Loomes reported in a recent article.

Biosimilars of etanercept

Biosimilars/General | Posted 20/06/2014

Last update: 20 November 2020 

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Biosimilars approved in the US

Biosimilars/General | Posted 14/08/2015

Last update: 14 October 2022

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).

Biosimilars of pembrolizumab

Biosimilars/General | Posted 14/10/2022

Pembrolizumab is a humanized (from mouse) monoclonal antibody that binds to, and blocks PD-1 located on lymphocytes. It is an anticancer medication used in the treatment of melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, urothelial cancer (cancer of the bladder and urinary tract) and renal cell carcinoma (kidney cancer).

EMA calls for biosimilar interchangeability across the EU

Biosimilars/General | Posted 23/09/2022

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued on 19 September 2022 a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar. This will allow more patients to have access to biological medicines necessary for treating diseases such as cancer, diabetes and rheumatic diseases.

Glosario de términos principales

Biosimilars/General | Posted 10/09/2021

Last update: 23 September 2022

Desde el lanzamiento del primer biosimilar en Europa en abril de 2006, se ha debatido de manera reiterada sobre el uso adecuado de la terminología relativa a los medicamentos biológicos, principalmente en inglés.