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- Title
Biosimilars: policy, clinical, and regulatory considerations.
- Authors
Gottlieb, Scott
- Abstract
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 for use in the policy discussion about biosimilars; the European Union system for biosimilars; and the current status of biosimilars legislation in the United States are described.
- Publication
American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2008, Vol 65, Issue 14 Suppl 6, pS2
- ISSN
1535-2900
- Publication type
Journal Article
- DOI
10.2146/ajhp080210