What lurks in the shadows of the openness hyperbole for biopharmaceuticals

摘要: 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 drug development. This article depicts these with particular focus European Medicines Agency (EMA) Biologics. We argue order promote development of innovative biologics biosimilars, EMA need carefully consider address such challenges.