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

Recent clinical trials transparency initiatives signify laudable progress. Yet, a closer look on legal developments reveals that the protection of commercially confidential information and personal data continues to pose substantial challenges for drug innovation. This article depicts these developments with a particular focus on the European Medicines Agency (EMA) and biologics. We argue that to promote the development of innovative biologics and biosimilars, the EMA must carefully consider and address such challenges.