10 May 2017

What pricing and reimbursement policies to use for off-patent biologicals? – Results from the second EBE biological medicines policy survey

Objective: Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the first biosimilar was approved in the European Union, but do policies in the Member States take the differences between biological medicines and small-molecule generics into account? To map the policy landscape in Europe, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey of pricing and reimbursement policies for off-patent biologicals....

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15 Mar 2017

Biosimilar product labels in Europe: what information should they contain?

To discuss current labelling of biosimilars in Europe, the European Biopharmaceutical Enterprises (EBE) and the European Association for Bioindustries (EuropaBio) held a multi-stakeholder workshop on...

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03 Aug 2016

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products

For the past two years, representatives from eight different pharmaceutical companies which manufacture biotechnological products have been discussing visible particles. The probability of seeing a...

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15 Sep 2015

EBE Concept Paper: Forced Degradation Studies for Therapeutic Proteins

04 Sep 2015

EBE White Paper on Personalised Medicine

Personalised medicine aims to deliver the right medicine to the right patient at the right time. It targets treatments to patients that are most likely to benefit from them, in contrast to the traditi...

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04 May 2015

A Risk-Based Approach to Sterile Filtration Bioburden Limits

4 May 2015:  Discussion of the current thinking in the Industry with Stakeholders at the CASSS CMC Strategy Forum Europe 2015....

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03 Feb 2015

Destination Europe

10 Dec 2014

Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe

The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar...

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30 Nov 2014

EBE and ESCHER launched new project ‘Pharmacovigilance of biologics’

Escher, the TI Pharma platform for regulatory innovation, launched a new project,‘Pharmacovigilance of biologics’ in November 2014. It will address the challenges of product and batch traceabilit...

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13 Nov 2014


Booklet Annex ...

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