Articles
- Biosimilars: Policy, clinical, and regulatory considerations, AJHP
- Implications of biosimilars for the future, AJHP
- Biosimilars: Illustration of scientific issues in two examples, AJHP
- Forum discusses biosimilars, better biologicals, AJHP
- The State of the Art in the Development of Biosimilars, Clin Pharmacol Ther
- NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives, J Natl Compr Canc Netw
Guidelines
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, [PDF] FDA
- Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, [PDF] FDA
- Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, [PDF] FDA
Other Resources
- FDA: Information on Biosimilars, FDA
- Accelerating the Adoption of Biosimilars, ASHP Advantage
