Biosimilars: policy, clinical, and regulatory considerations.

  • Scott L. Gottlieb
  • Published 2008 in
    American journal of health-system pharmacy : AJHP…

Abstract

PURPOSE The regulatory background surrounding biosimilars (biopharmaceuticals that are considered similar in composition to an innovator product, but not necessarily clinically interchangeable); equivalence, interchangeability, and unique considerations associated with biopharmaceuticals; the biopharmaceutical protein production process; scientific facts… (More)
DOI: 10.2146/ajhp080210

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