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.

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.

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].

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.

Biosimilars switching policies for Canada’s Newfoundland and Labrador, and Yukon

Biosimilars/General | Posted 04/05/2023

The Canadian provinces of Newfoundland and Labrador, and Yukon, become the 9th and 10th Canadian provinces to announce that they are adopting biosimilars switching policies.

Advancing biosimilar drug development with pharmacodynamic biomarkers

Biosimilars/General | Posted 27/04/2023

US Food and Drug Administration (FDA) researchers are studying the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. These studies could make the process of developing biosimilars more efficient and faster.

Spanish Psoriasis Group update biosimilar position statement

Biosimilars/General | Posted 14/04/2023

The use of biosimilar drugs in the treatment of moderate to severe psoriasis has changed the current therapeutic approach. Evidence from clinical trials and real-world experiences has led to an update in the positioning of the Spanish Psoriasis Group (GPS) [1].

Challenges for Spanish generics and biosimilars industry: sustainable profitability

Biosimilars/General | Posted 31/03/2023

Spain's generics and biosimilars industry is calling for their profitability to be guaranteed after authorities lowered the reference prices of over 1,000 drugs.

Lilly, Novo Nordisk and Sanofi slash prices of insulin in the US

Biosimilars/General | Posted 23/03/2023

In March 2023, major insulin manufacturers Eli Lilly (Lilly), Novo Nordisk and Sanofi announced price reductions of 70%, 75% and 78% respectively, for their most commonly prescribed insulins in the US, starting from first quarter of 2023 for Lilly and from 1 January 2024 for Novo Nordisk and Sanofi. The three companies control over 90% of the global insulin market. 

American College of Rheumatology position statement on biosimilars updated

Biosimilars/General | Posted 16/03/2023

In late 2022, the American College of Rheumatology (ACR) issued a position statement on biosimilars [1] in which they emphasized their strong belief that safe and effective treatments should be available to patients at the lowest possible cost. This is an update of previous position statements [2].