Author:
Alvarez Daniel F.,Wolbink Gertjan,Cronenberger Carol,Orazem John,Kay Jonathan
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.
Cited by
24 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献