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EuropaBio welcomes EMA revised Questions and Answers on Biosimilars


01 Oct 2012


Innovation & Enterprise

Press statement: 01.10.12


Last week the European Medicines Agency (EMA) published its revised Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.


EuropaBio members are supportive of updating the EMA Biosimilars Q&A to reflect regulatory experience with biosimilar applications since the Q & A was first published in 2008. We also support EMA’s efforts to differentiate the regulatory standards for biosimilars from those that support generic chemical medicines.


Biosimilar medicines are designed to be similar – but not identical - to their reference innovator medicine. We believe that the new EMA Q&A document provides needed additional clarity around the differences between generic medicines and biosimilars. It also clearly reflects the fact that while generic medicines are generally considered interchangeable with their reference product, this cannot be assumed to be the case for biosimilars.


In this context EuropaBio welcomes the statement that patients should speak to their doctor and pharmacist concerning ‘questions related to switching from one biological medicine to another’. We believe this guidance will ensure the prescribing physician must always be consulted in any discussion to switch their medicine, which is essential for clinical management and for proper pharmacovigilance.


EuropaBio also notes that while the revised EMA Q&A document contains specific language on how the safety of biosimilar medicines is monitored, there are no references to the fact that biosimilars are already subject to additional post-market safety monitoring. Such clarification would help patients and the general public understand that their safety is paramount in the existing framework supporting biosimilar development and use in Europe.


Meeting regulatory expectations is not without its challenges as evidenced by the fact that several biosimilar applications have been rejected by the EMA, withdrawn, and/or re-worked by their manufacturers in order to satisfy the standards established by EMA. Furthermore, given their specificities, it should also be noted that biosimilar medicines may not be indicated for all the diseases for which their reference products have been authorized.


Generics and biosimilars have an important role to play in fostering competition in the market place, and thereby contributing to the sustainability of healthcare budgets.




To view the EMA Q&A document, please click here


About EuropaBio

EuropaBio is the European Association for Bioindustries, bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 56 corporate members, 11 associate members, 3 BioRegions and 19 National Biotechnology Associations- representing some 1800 small and medium sized enterprises.


For further information, please contact:


Tom Moore, Amgen (Europe) GmbH

Biosimilars Topic Leader  - EuropaBio

Phone: +41 41 36 904 79

GSM: +41 78 750 88 13



Rosalind Travers

Manager, Communications & National Associations

Phone: +32 (0) 2 739 1173

GSM: +32 (0) 478 680 301