What lurks in the shadows of the openness hyperbole for biopharmaceuticals?. Issue 3 (11th March 2019)

• Record Type: Journal Article
• Authors: Neethu, R.; Minssen, Timo
• Is Part Of: Drug development research. Volume 80:Issue 3(2019)
• Page Start: 282
• Page End: 284
• Publication Date: 2019-03-11
• Subjects: biologics -- clinical trial data -- drug development -- transparency; Drug development -- Periodicals; Drugs -- Research -- Periodicals; 615.19
• DOI: 10.1002/ddr.21526
• Languages: English
• ISSNs: 0272-4391

Abstract

Abstract: Recent advances in transparency initiative signify laudable developments. Yet, a closer look on the legal developments indicates that commercially confidential information and personal data will continue to pose persisting challenges for clinical trial transparency and drug development. This article depicts these developments with a particular focus on European Medicines Agency (EMA) and Biologics. We argue that in order to promote the development of innovative biologics and biosimilars, the EMA will need to carefully consider and address such challenges.