Biosimilars: considerations for an abbreviated pathway.
US Food and Drug Administration, Office of Biotechnology Products, Silver Spring, MD 20993, USA. steven.kozlowski@fda.hhs.gov
Steven
S
Kozlowski
Rachel
R
Behrman
D001709:Biotechnology / Q000592:standards; D017277:Drug Approval; D004345:Drug Industry / Q000592:standards; D016568:Drugs, Generic / Q000592:standards*; D015507:Drugs, Investigational / Q000592:standards; D006801:Humans; D017387:Investigational New Drug Application; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards*
D016568:Drugs, Generic; D015507:Drugs, Investigational; D004364:Pharmaceutical Preparations