The European Commission launched recently additional translations of the Q&A paper “What I Need to Know about Biosimilar Medicines – Information for patients’’ making it available now in 23 official European languages, in order to provide patients with easy-to-understand information about biosimilar medicines. The Q&A was written to empower patients by providing answers to the most-frequently-asked questions on biosimilar medicines.
What are biosimilar medicines? How are they produced? How are they approved? Are they safe? – These questions and many more are addressed in this paper. Empowering patients to engage, discuss and participate in decisions on their treatment options is key to improving patient outcomes and contributing to the effective treatment of their individual condition(s).
In Europe, the introduction of biosimilar medicines brings competition, with the potential to improve patient access to biological medicines and contribute to healthcare system sustainability. Biosimilar medicines help treat many complex diseases, including cancer, diabetes, and autoimmune diseases (such as rheumatoid arthritis and inflammatory bowel disease). Biosimilar medicines have been used safely in the EU since 2006 as an alternative to reference medicines.
This Q&A is an initiative by the European Commission Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG Grow) on access to biosimilar medicines in Europe, in relation to the Corporate Responsibility Programme. This consensus information on biosimilar medicinal products was drafted by and for patients together with representatives of the European Medicines Agency, the European Commission and concerned stakeholders [the European Patients Forum (EPF), the European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA), the Standing Committee of European Doctors, European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for BioIndustries (EuropaBio) and Medicines for Europe]. The Q&A was first launched in English in January 2017.
The above stakeholders would like to congratulate the European Commissions’ DG GROW and the European Medicines Agency on the developments during this programme. The Patient Q&A amongst other documents, such as “Biosimilars in the EU - Information guide for healthcare professionals” and “What you Need to Know about Biosimilar Medicinal Products - A Consensus Information Document”, have contributed significantly to the increased understanding and acceptance of biosimilar medicines.
The Standing Committee of European Doctors (CPME) represents national medical associations across Europe. We are committed to contributing the medical profession’s point of view to EU institutions and European policy-making through pro-active cooperation on a wide range of health and healthcare related issues.
EPF currently represents 74 members, which are national coalitions of patient’ organisations and disease-specific patient organisations working at European level. EPF reflects the voice of an estimated 150 million patients affected by various chronic diseases throughout Europe.
EPF’s vision is that all patients with chronic and/or lifelong conditions in the EU have access to high quality, patient-centred equitable health and social care.
The EPF strategic goals focus on areas such as health literacy, healthcare design and delivery, patient involvement, patient empowerment, sustainable patients’ organisations and non-discrimination. For more information, visit www.eu-patient.eu.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world. For more information, visit www.efpia.eu.
EuropaBio, the European Association for Bioindustries, promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents 79 corporate and associate members and bio-regions, and 17 national biotechnology associations in turn representing over 1800 biotech SMEs. For more information, visit www.europabio.org.
Medicines For Europe
Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information, visit www.medicinesforeurope.com.
The Biosimilar Medicines Group is a sector group of Medicines for Europe and represents the leading companies developing, manufacturing and marketing biosimilar medicines across Europe. Our members bring competition to the biologic medicines market, thereby increasing access to highly innovative medical treatments for patients in Europe and around the world, and supporting the sustainability of the European healthcare systems.