COMMENTARY What lurks in the shadows of the openness hyperbole for biopharmaceuticals? R. Neethu | Timo Minssen Centre for Advanced Studies in Bio-Medical Innovation Law (CeBIL), University of Copenhagen, Copenhagen S, Denmark Correspondence R. Neethu, Centre for Advanced Studies in Bio-Medical Innovation Law (CeBIL), Karen Blixen Plads 16, 2300 København S, Søndre Campus, University of Copenhagen, Copenhagen S 2300, Denmark. Email: rajam.neethu@jur.ku.dk Funding information Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme, Grant/Award Number: NNF17SA027784 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 bio- logics and biosimilars, the EMA will need to carefully consider and address such challenges. KEYWORDS biologics, clinical trial data, drug development, transparency In July 2018, the European Medicines Agency (EMA) announced its first report (EMA’s proactive publication, 2018) covering 1 year of the implementation of its policy on the publication of clinical data (Policy 0070) (European Medicines Agency, 2014). This unprecedented flag- ship policy aims to enhance open access to clinical data submitted in support of marketing authorization applications. Since gaining momentum in 2010 (European Medicines Agency, 2010), the EMA’s proactive transparency policies have played an important role in shaping the global developments toward increased sharing of clinical trials data which can also be found in other Jurisdic- tion such as the U.S and Canada (Woollett & McCamish, 2011). The EMA’s transparency policy increases disclosure of clinical reports including clinical overviews, study reports, and individual patient data. Under this policy while disclosing clinical trial reports, personal data and trade secrets or commercially confidential informa- tion (CCI) are anonymized and made obscure. This is done through the process of redaction, which involves blackening of relevant portions of the report before releasing them to the public. In proceeding with a request for redaction, the EMA makes an assessment of the informa- tion provided in the clinical trial report and will take into account the justification provided by the applicant with regard to factors such as the nature of the product, the competitiveness of the therapeutic market, the novelty of the clinical development, and so on. In addition to EMA’s policy, the new EU clinical trials regulation also offers significant changes in relation to data transparency by requiring that all information pertaining to clinical trials be part of a publicly accessible database. Yet, if specific conditions under the regu- lation are met, CCI will be protected (Article. 81(4), 2014). The EMA’s report lists 50 medicines for which clinical data were published and reveals inter alia 454 instances where redactions were requested based on claims of CCI. Of those 24% were accepted and 76% were rejected (EMA’s proactive publication, 2018). The CCI redactions accepted by the EMA fall broadly within two categories: 55% of the redacted CCI were of a clinical nature as opposed to 45% relating to quality. Unsurprisingly, the EMA praises the report as a suc- cess for transparency. But does this appraisal also hold true for bio- logics and biosimilars? Under the present “Policy 0070,” the EMA publishes clinical data submitted by companies to support their regulatory applications for human medicines under the centralized procedure, which is manda- tory for both biologics (European Medicines Agency, 2014). Biologics are medicines made or extracted from living organisms, tissues, or cells. Biosimilars are biological medicine highly similar to another bio- logical medicine already approved in the EU (called “reference medi- cine”) in terms of structure, biological activity and efficacy, safety, and immunogenicity profile. A biosimilar is not regarded as a generic of a biological medicine because the natural variability and more complex manufacturing of biological medicines do not allow an exact replica- tion of the biologic drug. Every batch of reference drug is only biosi- milar for first batch of reference and it is not exactly the same because its biological product not synthetic. In fact, the batches of ref- erence drugs are similar to the first run. The EMA’s guidance and the ICH tripartite comparability guide- lines require regulatory approval for biosimilars following the perfor- mance of a series of extensive assessments to demonstrate the biosimilarity to the reference product (Multidisciplinary, n.d.; World Received: 12 January 2019 Revised: 18 February 2019 Accepted: 25 February 2019 DOI: 10.1002/ddr.21526 Drug Dev Res. 2019;1–3. wileyonlinelibrary.com/journal/ddr © 2019 Wiley Periodicals, Inc. 1