title: Letter--Draft FDA Guidance "Considerations in Demonstrating Interchangeability with a Reference Product": Overview and Presentation-Related Concerns.
abstract: Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies, and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.
authors.affiliation: 1 EB Rubinstein Associates.
authors.forename: Elan
authors.initials: E
authors.lastname: Rubinstein
mesh_terms: D001688:Biological Products / Q000592:standards* / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000592:standards* / Q000627:therapeutic use*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D006801:Humans; D010593:Pharmaceutical Services / Q000331:legislation & jurisprudence; D010604:Pharmacy / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals