Biosimilars/General

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 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.

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].

Biosimilars approved in Europe

Biosimilars/General | Posted 08/07/2011

Last update: 1 July 2022

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.

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.