A qualitative study of biosimilar manufacturer and regulator perceptions on intellectual property and abbreviated approval pathways

Affiliations

• ¹ Copenhagen Centre for Regulatory Science (CORS), Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
• ² Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
• ³ Social Pharmacy, Department of Pharmacy, Faculty of Pharmacy, Uppsala University, Uppsala, Sweden.
• ⁴ Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
• ⁵ LEO Pharma A/S, Ballerup, Denmark.
• ⁶ Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), Faculty of Law, University of Copenhagen, Copenhagen, Denmark.
• ⁷ Drug Delivery and Biophysics of Biopharmaceuticals, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
• ⁸ Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
• ⁹ Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. asarpatwari@bwh.harvard.edu.