Press Releases

24 Jan 2014

EBE statement on French substitution policy

The French Social Security Bill permits, under certain conditions, a restricted form of substitution of biosimilar products by pharmacists. This differs, however, from the substitution policies for generic products. The EBE statement clarifies the background and sets out the industry stance on this issue....

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16 Dec 2013

Omics-technologies: The Biopharma industry welcomes the European Commission’s report

European Biopharmaceutical Enterprises (EBE), the trade association representing the views of biopharmaceutical companies using biotechnology to develop innovative therapies, welcomes the European Commission’s recently published report on “Use of '-omics' technologies in the development of personalised medicine” (the Omics report). The Omics report carefully highlights a number of key opportunities and challenges in basic and clinical research that will impact the development of biomarkers, companion diagnostics and personalised medicines in the EU....

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07 Nov 2013

EMA Biosimilars Workshop Press Statement 5.11.2013

EBE and Europabio welcome revisions of EMA key principles for Biosimilar Guidelines which will strenghten the Biosimilar pathway in Europe and build confidence amongst clinicians and patients....

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03 Oct 2013

Small and Medium Sized Biopharmaceutical Companies endorse further clinical data sharing but concerned about implementation as proposed.

European Biopharmaceutical Enterprises, EBE, a specialised group of European Federation of Pharmaceutical Industries and Associations, EFPIA, recognises the potential for scientific and public health benefits of providing greater access to information from clinical trials. Majority of EBE members are small and medium sized biopharmaceutical companies they share EFPIA’s concerns of which could put at risk the promotion of public health, both in Europe and internationally: risks of de-identification of patient data, sharing of companies’ commercially confidential information, and commercial consequences of secondary analysis of data for approved products. ...

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10 Jul 2013

IMI2 Launch to Further Innovative Medicines Initiative Success

The European Biopharmaceutical Enterprises – EBE - a specialised group of EFPIA - the European Federation of Pharmaceutical Industries and Associations, is pleased to announce the European Commission launch of the IMI2 research funding initiative, which will build upon the success of the Innovative Medicines Initiative in a continued effort to bring innovative solutions to patients....

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08 May 2013

MOCA Report a welcome stepping stone, but access to orphan medicinal products remains unfinished business

EuropaBio, EFPIA and EBE welcome the final report of the Working Group on Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA-OMPs) which was endorsed by the Steering Group of the Process on Corporate Responsibility in the field of Pharmaceuticals, and published on 6 May 2013 by the European Commission....

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19 Apr 2013

EFPIA, EBE and EuropaBio welcome European Commission Consensus Information Document on biosimilars in the European pharmaceutical environment

The European Federation of Pharmaceutical Industries & Associations (EFPIA), its specialised group the European Biopharmaceutical Enterprises (EBE) and the European Association for Bioindustries (EuropaBio) welcome the consensus information document on biosimilars that was approved by the European Commission Steering Group on Access to Medicines in Europe on 17th April. The Commission will present the document at the BIO international Convention in Chicago on 23rd April. The document discusses the specifics around biosimilar medicinal products, the requirements for their marketing authorization in the EU, their market performance, and the necessary conditions within the EU pharmaceutical market to ensure there is informed and adequate use of these medicines....

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17 Jul 2012

EU Commission Regulation on Clinical Trial proposal

The EU Commission has published today the draft legal proposal on the revision of the regulatory framework for clinical trials in Europe.EBE Executive Director (acting) Mrs Titta Rosvall-Puplett comments on the EU Commission proposed new regulation:...

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