FDA and EMA Biosimilar Approvals

Affiliations

• ¹ 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.
• ² 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.
• ³ Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA.