Key regulatory and legal developments for biosimilars in the EU

5^th European Biosimilars Congress

June 27-29, 2016 Valencia, Spain

Peter Bogaert

Covington & Burling LLP, Belgium

Posters & Accepted Abstracts: J Bioanal Biomed

Abstract :

The EU operates a well-established biosimilars review process that has more than a decade of experience. Almost all biosimilar applications are reviewed by the EMA, which has issued extensive guidance that covers general principles for review of biosimilars and also addresses specific aspects for various active ingredients. The practices and guidelines are also regularly updated in light of regulatory experience and international developments. Key areas of attention now are: (i) What role should the EMA play with regard to switching and interchangeability? This must be assessed also against the background of the separation of EU and national powers under the EU treaties, which provide, for instance, that the Member States have responsibility for â�?�?the organisation and delivery of health services and medical care.â�? (ii) What role could the EMA play in the context of HTA? Should this focus on relative efficacy or relative effectiveness and would this have an impact on biosimilars? (iii) What role can big data play for biosimilars? The regulatory approval system must also be seen in the broader context, which can have a significant impact on real use of biosimilars. This includes the INN policies of the WHO and the role of public procurement and its practical implications for switching. The talk will focus on these elements and also provide a general update on the regulatory situation in the EU. Recently, for instance, some applications for non-biotech biosimilars were made at the national level and add a new dimension to the picture.

Biography :

Email: pbogaert@cov.com