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Biosimilar Medicines

Biological medicines are made up of proteins that are naturally produced in the human body. Since their development in the 1980s they have helped treat diseases such as cancers, diabetes, multiple sclerosis, autoimmune diseases such as rheumatoid arthritis, heart attacks and strokes.

Many of these original biological medicines have reached the end of their patents, providing the opportunity for medicines which are similar (in terms of quality, safety and efficacy) to the original medicine to be produced and made available to patients. In Europe, these are called biosimilar medicines.

As more and more biosimilar medicines become available to patients there are important issues for patients and patients' organizations including the importance of regulatory transparency, good patient information and patient-health professional decision-making in assessing treatment options, that must be addressed.


Biological and Biosimilar Medicines: An Information and Advocacy Toolkit for Patients' Organizations, 2013

Since IAPO's first Briefing Paper in 2006, there have been many developments in terms of the regulation of biosimilar medicines and their coming to market in a number of countries. This raises the need for patients’ organizations and patients to be informed as to the situation and what it means for them.

This Toolkit was developed for patients’ organizations across the world to provide up-to-date, evidence-based information on the science, technology and regulatory information relevant to biological and biosimilar medicines. It also offers tips on advocacy and further resources. IAPO hopes this Toolkit will allow patient advocates to make informed judgements on the value of biological and biosimilar medicines and actively engage in debate and discussion with other stakeholders involved in healthcare.

To order a printed copy of the Toolkit please fill in this order form and return to IAPO by email info@patientsorganizations.org or by post.


IAPO Webinar on Biological and Biosimilar Medicines - 12 December 2013

On 12 December 2013 IAPO held a webinar for member patients' organizations on the issue of biological and biosimilar medicines. The webinar provided information about IAPO's work on the topic in 2013 and IAPO's Information and Advocacy Toolkit. It also provided an overview of what these medicines are, why they are important and what patients' organizations can do on the topic. You can find the slides here.  


IAPO Workshop on Biosimilar Medicines - Geneva, Switzerland - 2-3 May 2013

On the 2-3 May 2013, IAPO held a Workshop on Biosimilar Medicines in Geneva. The workshop brought together over 19 patients’ organization representatives and other healthcare stakeholders from around the world to participate in an exciting programme which explored the impact of biological and biosimilar medicines on patient care including issues of access and availability. The workshop was attended by healthcare stakeholders such as the European Generic Medicines Association and International Hospital Federation, as well as the sponsors of IAPO’s Biosimilar Medicines Project.

The workshop covered topics such as how biological and biosimilar medicines can address current and future needs for diagnosis, prevention and treatment, and learning and best practices to facilitate patient access to these medicines, allowing time for discussion and debate.

There were presentations from Dr Hye-Na Kang from the World Health Organization, Dr Pekka Kurki, Finnish Medicines Agency, and Michael Reilly, Alliance for Safe Biologic Medicines. The workshop ended with action planning for the future and IAPO will support patients’ organizations in further developing and implementing their action plans where possible.

IAPO also used this opportunity to gain detailed feedback regarding the Draft Updated Briefing Paper on Biosimilar Medicines which aims to provide patients’ organizations with useful and detailed information regarding biological and biosimilar medicines.

Click here for the Meeting Report. See full list of participants here.



Previous work on Biosimilar Medicines:

IAPO Biosimilars Workshop – Brussels, Belgium - 4 December 2006

On December 4 2006, IAPO held a workshop in Brussels for patient representatives and other stakeholders to provide further information and discuss the issues surrounding the growing prevalence of  biotechnology medicine copies and in particular, biosimilar medicines.

The event was attended by delegates from patients’ organizations that represented different disease areas and came from across Europe, as well as representatives from professionals’ organisations, including the International Council of Nurses and the International Pharmaceutical Federation. To read more about the workshop and download the presentations, click here.


IAPO Briefing Paper on Biosimilar Medicines, 2006

IAPO has published a Briefing Paper to educate and inform patients' organizations on the introduction of biosimilar medicines.  This was published in September 2006 and will be launched at the European Parliament in Brussels on the 5 December 2006. 

The Briefing Paper outlines issues for consideration by patients and patients' organizations and also brings together stakeholder perspectives on the most important issues relating to the introduction of biosimilar medicines. 

The Briefing Paper is being provided to over 1,000 patients' organizations around the world free of charge. 

You can access the briefing paper here.

Development of the Paper has been supported financially by an unrestricted educational grant from Amgen. 


Please contact info@patientsorganizations.org for further information on IAPO's work on biosimilar medicines.

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