What lurks in the shadows of the openness hyperbole for biopharmaceuticals?

TY - JOUR

T1 - What lurks in the shadows of the openness hyperbole for biopharmaceuticals?

AU - Rajam, Neethu

AU - Minssen, Timo

PY - 2019/5/11

Y1 - 2019/5/11

N2 - 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.

AB - 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.

UR - https://www.ncbi.nlm.nih.gov/pubmed/30856292

U2 - 10.1002/ddr.21526

DO - 10.1002/ddr.21526

M3 - Journal article

C2 - 30856292

SN - 0272-4391

VL - 80

SP - 282

EP - 284

JO - Drug Development Research

JF - Drug Development Research

IS - 3

ER -