Universal Access to Health, How Can We Contribute?

AGENDA

9.30 Coffee & Registration

10.00 Introduction: the event, rationale of the partnership, 4th edition, goal of the debate, setting

Moderator:  Sarantis Michalopoulos, Euractiv

10.15 Welcome Address and MEPs’ perspectives

  • MEP José Inácio Faria, EPP group, PT
  • MEP Andrey Kovatchev, EPP group, BU

10.30 European Commission’s overview

  • Sylvain Giraud, Head of Unit, DG Santé

10.45 Stakeholders’ perspectives on improving access to healthcare

  • Nicola Bedlington (EPF)
  • Arnaud Emériau (ESIP)
  • Yannis Natsis (EPHA)
  • Adrian van den Hoven (Medicines for Europe)

11:45  Exchange of views

12:15  Questions and answers

12.30  Networking Lunch

REGISTRATION

Tweetup with Jacek Glinka | Friday 24 March 2017 | 10.00 – 10.45 (CET)

15th Biosimilar Medicines Conference

BIOSIMILAR MEDICINES: A GAME CHANGER FOR HEALTHCARE SUSTAINABILITY

Friday 24 March 2017 | 10.00 – 10.45 (CET)

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Positioning Statements on Physician-led Switching for Biosimilar Medicines

Biosimilars – the question of trials and approval

by Robin Foà

Robin Foà, MD from the Sapienza University, Rome, Italy discusses the question of how the trials on biosimilars should be run and what needs to be done for biosimilars to get approved. According to Prof. Foà, this is a difficult question and he points out that the European Medicines Agency (EMA) has stated that extrapolation is acceptable. He talks about the importance of demonstrating the safety and efficacy of biosimilars and discusses when extrapolation may be acceptable. Prof. Foà further argues that it is unrealistic to repeat all trials. Recorded at the European Hematology Association (EHA) 2016 Annual Congress in Copenhagen, Denmark.

Biosimilars: can the dream of affordable cancer care come true?

by Paul Cornes

Cancer is the world’s biggest killer, and the complex biological medicines used to treat it are expensive. Even the world’s richest countries will struggle with the cost of these drugs and so tackling the issue of affordable cancer care is something we need to address now. One of the solutions could be biosimilars. But what are they, do we need them and are they similar enough to the originator products to use them safely in our patients? Opinion is divided among physicians but some experts say this is down to a lack of information and education. We interviewed top biosimilars expert, Dr Paul Cornes, on this burning subject, which is dividing opinions in the field of oncology. Dr Cornes discusses the cost of biologic medicines, the introduction of biosimilars and the regulatory pathways that have been put in place to ensure safety and efficacy remains. He talks about the methods by which biosimilars can be ‘extrapolated’ across multiple indications, as well as touching on some interesting insights into the manufacturing of the biologic molecules that oncologists have been using, without question, for years. Watch the entire comprehensive interview series soon on http://www.VJHemOnc.com to find out if the dream of affordable cancer care can come true. This programme has been supported by Napp Pharmaceuticals Ltd through an unrestricted educational grant to Magdalen Medical Publishing.

Biologics and biosimilars explained

Medicines for Europe – Better Access. Better Health

 

15th Biosimilar Medicines Conference: a game changer for healthcare sustainability

10th Medicines for Europe Pharmacovigilance Conference. Save the date!

 

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)