Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic

Biosimilars in the EU – Information guide for healthcare professionals – now available in 23 languages

Switch Management between Similar Biological Medicines. A Communication and Information Guide for Nurses.

Educational material on biosimilar medicines, developed by IGBA (International Generic and Biosimilar Medicines Association)

What are the key messages of the ESMO 2017 symposium?

Biosimilars — Can the dream of affordable cancer care come true?

A Clinician´s Guide to Biosimilars in Oncology: Understanding the Science of Extrapolation and Interchangeability

Q&A for patients – Biosimilar medicines explained

The European Commission has published improved information for patients on biosimilar medicines. The Q&A are available in 7 languages (English, French, German, Italian, Polish, Portuguese and Spanish) offering patients access to unbiased and reliable information.

Biological medicines (including biosimilars) come from living organisms (cells) that have been modified using biotechnology.

A biosimilar medicine is developed to be highly similar to an existing biological medicine. They have a great importance in the treatment of severe diseases such as cancers.

Biosimilars have significant potential to create competition in the biological medicine market and provide patients with broader affordable access to state of the art medicines.

The Q&A document was first published in 2013 as part of the consensus information paper, ‘What you need to know about biosimilar medicinal products‘. The main goal of this revision is to provide patients with information in language that is easy to understand, despite the complexity of the concept.

The next stakeholder workshop organised by the Commission on the uptake of biosimilar medicines in the EU is on 5 May 2017.

What I need to know about Biosimilar Medicines – Information for patients  (7 MB)

EAHP satellite on Biosimilar medicines

Maarten Van Baelen – Intro + Niklas Ekman – Biosimilars from the perspective of an EU regulator

Maarten Van Baelen

Niklas Ekman

Arnold Vulto – Biosimilars concerns of prescribers and how to address them as a hospital pharmacist

Arnold Vulto

Paul Cornes – Biosimilars – can we do without them

Paul Cornes

Please find  the report of the satellite symposium held at the EAHP conference here.

What you Need to Know About Biosimilar Medicinal Products

European Commission Consensus Information Document: What you Need to Know About Biosimilar Medicinal Products.

To view the full report, please click here.