EMA & Biosimilar Update: Trends from marketing authorisation applications, scientific advice procedures and policies – Peter Richardson, EBG Biosimilars 2015, London (PPT)

24 April 2015

Policy

The Science of Extrapolation – Martina Weise, EBG Biosimilars 2015, London (PPT)

23 April 2015

Policy

To view the full presentation, please click here. Part I […]

Considerations on WHO’s BQ Proposal – Joerg Windisch, 60th INN Consultation WHO, Geneva, 13 April 2015 (PPT)

13 April 2015

Policy

French Parliament Public Hearing on Biosimilar Medicines, Paris, 29 January 2015 – Intervention from EMA Spokesperson Camille Vleminckx

29 January 2015

Policy

Labelling & Naming – EBG Perspective, DIA Berlin 2014

3 December 2014

Policy

WHO BQ Proposal – EGA’s perspective, 59th INN Consultation, WHO, Geneva, 14 October 2014

14 October 2014

Policy

EMA mAb Workshop – Guideline on Similar Biological Medicinal Products

31 October 2013

Policy, Video

EMA mAb Workshop – Quality Target Product Profile in the Development of a Biosimilar

31 October 2013

Policy, Video

EMA mAb Workshop – Stepwise Approach to Non-Clinical Program

31 October 2013

Policy, Video

International Generic Pharmaceutical Alliance (IGPA) Letter Regarding TGA Guidance Titled “Evaluation of Biosimilars”, 2013

18 September 2013

Policy