EGA Handbook on Biosimilar Medicines
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A copy of the EGA Handbook on Biosimilar
Medicines is available by e-mail using this link to the
.
Please include your name, company/organisation, and position with your request.
CONTENTS
- Why are Biosimilar Medicines Important?
- Context
- Why has the term ‘Biosimilar Medicine’ been chosen?
- Science and Technology behind Biosimilar Medicines
- Regulation of Biosimilar Medicines
- Access to Biosimilar Medicines
- Evolving Landscape of Biosimilar Medicines
- Further Information
- Glossary
FOREWORD
The first five biosimilar medicines were
approved for use in Europe in 2006
and 2007.
This short guide is intended to be the
reference source for those who need to
understand what these new medicines
are; why they are becoming more
important; their benefits and questions
raised by this emerging type of vital
medicine.
It will be particularly useful to:
- Patients and Patient Advocacy Groups,
- Clinicians and Prescribers,
- Retail and Hospital Pharmacists,
- Those responsible for funding health and healthcare
on a regional or national basis,
- National pricing and reimbursement authorities,
- Politicians and advisers, and
- Policy makers.
This handbook provides the background
to the emergence of biosimilar
medicines, and the clinical and health
economic benefits they offer to patients,
clinicians and healthcare providers.
It describes the science and technology
behind biosimilar medicines; how they
are produced and regulated, and also
covers the questions surrounding
them, namely:
- terminology,
- quality, safety and efficacy,
- comparability,
- non-clinical tests and clinical trials,
- pharmacovigilance,
- immunogenicity,
- access to medicines,
- identification and traceability,
- interchangeability and substitution.
The handbook focuses on the current
situation in the European Union (EU)
and concludes with a summary of the
developments likely to occur in the
near future.
A glossary of terms, highlighted in bold
in the text, and a list of acronyms or
abbreviations are also provided at the
back of the handbook.
On behalf of the EGA Board of Directors
I believe that this handbook will greatly
enhance the knowledge about biosimilar
medicines and understanding of their
public health contribution.
I thank you for your time in reading
this document.
Greg Perry,
Director General
EUROPEAN GENERIC
MEDICINES ASSOCIATION
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