By Michael S. Reilly, Esq. Executive Director, ASBM If a recent headline describing the biosimilar experience in Europe were to be believed, one would expect that biosimilars have captured a great deal of the biologics marketplace. The headline, “Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns” suggests these complex medicines are perfectly safe […]
On May 30th, in partnership with the Connecticut State Medical Society, ASBM presented a 2-hour Continuing Medical Education (CME) course entitled “Biosimilars: New Choices, New Challenges”. The event began with remarks by CSMS President Jeff Gordon, MD, who is Medical Director of Hematology-Oncology Services at Day-Kimball Hospital in Putnam, CT. Dr. Gordon emphasized the great excitement […]
On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product. The comments may be read in their entirety below, or are available here as a PDF. May 22, 2017 Division of Dockets Management (HFA-305)here. Food and Drug Administration Department of Health and Human Services […]
