Developing the Nation’s Biosimilars Program
Steven Kozlowski, M.D., Janet Woodcock, M.D., Karen Midthun, M.D., and Rachel Behrman Sherman, M.D., M.P.H.
New England Journal of Medicine
August 4, 2011
Biologic products developed over the past three decades and approved by the Food and Drug Administration (FDA) now provide important therapeutic options for a variety of serious clinical conditions. Therapeutic biologics such as genetically engineered recombinant proteins and monoclonal antibodies represent a large portion of newly approved therapies for conditions such as chronic inflammatory diseases and cancer. Biologic enzyme-replacement therapies provide clinical benefits in previously untreatable genetic disorders.