Biosimilars/General

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].

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 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).

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.

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.

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.

American Academy of Ophthalmology biosimilars guidance details

Biosimilars/General | Posted 01/07/2022

The American Academy of Ophthalmology (AAO) recognizes the potential societal value of biosimilars for improving care of patients with eye disease. Biosimilars should have sufficient research demonstrating their safety and effectiveness for treatment of eye disease. In January 2022, the AAO issued a policy statement on the biosimilars in ophthalmologic use [1].

Current status of monoclonal antibody biosimilars approved in Latin America

Biosimilars/General | Posted 24/06/2022

By the end of 2021, biosimilar antibodies of rituximab, trastuzumab, infliximab, adalimumab and bevacizumab were expected to be commercialized in Latin America with 25 different brand names.

Overview of monoclonal antibody biosimilars in Latin America

Biosimilars/General | Posted 17/06/2022

This article describes the current situation of biosimilar monoclonal antibodies in 10 countries of Latin America and their potential to reduce the cost of antibody therapies.

American Academy of Ophthalmology biosimilars position statement published

Biosimilars/General | Posted 10/06/2022

The American Academy of Ophthalmology issued a policy statement on the use of biosimilars in ophthalmic practice in January 2022 [1].

US prescription drug expenditure projection report

Biosimilars/General | Posted 03/06/2022

United States expenditure on pharmaceuticals was up in 2021, finds a report published in American Journal of Health-System Pharmacy [1]. It also highlights that increased uptake of biosimilars is allowing for healthcare savings yet overall spending on drugs in the US will increase by up to 6% in 2022.

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