Publications

28 Aug 2017

Escher “Pharmacovigilance of Biologics” Project – Outcome

The 2015 Escher project ‘Pharmacovigilance of Biologics’ investigated how adverse reactions to biologic medicines are recorded in different settings in the Netherlands, aiming to understand ho...

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02 Jun 2017

Reinventing the European Advanced Therapies Sector: An Interview with Eduardo Bravo

In this interview with Eduardo Bravo, CEO of TiGenix and President of the Board of the European Biopharmaceutical Enterprises (EBE), we discuss the increasing challenge for EU biotech companies to commercialise at home, and the accelerating departure of cutting-edge European biotech start-ups through IPOs and, increasingly, mergers and acquisitions. Interview by Duane Schulthess/Vitaltransformation.com ...

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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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22 Feb 2016

EuropaBio and EBE host a multi-stakeholder debate on the labelling of biosimilar medicines

On 2 February 2016, EuropaBio, the European Association for Bio Industries, and EBE, the European Biopharmaceutical Enterprises, jointly facilitated a multi-stakeholder workshop in Brussels on the...

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15 Sep 2015

EBE Concept Paper: Forced Degradation Studies for Therapeutic Proteins

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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

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