GaBI Journal publishes a series of peer-reviewed scientific articles addressing almost all aspects of biosimilar medicines.
The objective of the Biosimilars educational series is to provide a structural compilation of expert peer reviewed papers covering the current issues and practical experiences on the use of biosimilars, as well as the future development of biosimilars. The goal is to share academic/scientific and practical information on biosimilar medicines with the wide public who are involved in the development, application and use of biosimilars, and also that patient access to modern biosimilar therapies can be enhanced.
The Biosimilars educational series is to be compiled into an educational book intended for healthcare practitioners, including physicians, pharmacists and regulators.
To avoid any confusion: for GaBI Journal the definition of a biosimilar is rather straightforward. Only those products that are licensed (or intended for licensing) by the European Medicines Agency or the US Food and Drug Administration as biosimilars fulfill the basic quality criteria of a biosimilar, other products will not be discussed.
The educational book series covers a wide range of topics:
- how biosimilars are being perceived by different stakeholders
- how biosimilars are defined, regulatory aspects, guidelines both from EMA and/or FDA
- how biosimilars are developed, produced and characterized and released for clinical use (quality control)
- chemical, pre-clinical and clinical aspects (including efficacy and safety like immunogenicity), pharmacovigilance and post-marketing studies
- different types of biosimilars: small proteins and antibody-biosimilars under development
- practical aspects like substitution and interchangeability
- economical aspects like price setting and reimbursement
- the role patients can play to improve acceptance of biosimilars
- the future of biosimilars development: globalization of the regulatory frameworks
The Biosimilars for Healthcare Professionals book is a useful tool for internal or external training for healthcare professionals, and for distribution at national and international events/conferences for medical practitioners. Contact us to reserve a copy or for a bulk purchase request.
For further information on the editorial topics, please contact the Publisher.