Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?

Author:

Alvarez Daniel F.,Wolbink Gertjan,Cronenberger Carol,Orazem John,Kay Jonathan

Funder

Pfizer

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference46 articles.

1. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015. https://www.fda.gov/media/82647/download. Accessed 11 Nov 2019.

2. US Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product. Guidance for industry. 2019. https://www.fda.gov/media/124907/download. Accessed 21 May 2019.

3. McKinley L, Kelton JM, Popovian R. Sowing confusion in the field: the interchangeable use of biosimilar terminology. Curr Med Res Opin. 2019;35(4):619–21.

4. Tothfalusi L, Endrenyi L, Chow SC. Statistical and regulatory considerations in assessments of interchangeability of biological drug products. Eur J Health Econ. 2014;15(Suppl 1):S5–11.

5. Bridges SL Jr, White DW, Worthing AB, Gravallese EM, O'Dell JR, Nola K, et al. The science behind biosimilars: entering a new era of biologic therapy. Arthritis Rheumatol. 2018;70(3):334–44.

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