These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
4. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States. Ahmed I; Kaspar B; Sharma U Clin Ther; 2012 Feb; 34(2):400-19. PubMed ID: 22244050 [TBL] [Abstract][Full Text] [Related]
5. Biosimilars: A consideration of the regulations in the United States and European union. Daller J Regul Toxicol Pharmacol; 2016 Apr; 76():199-208. PubMed ID: 26732800 [TBL] [Abstract][Full Text] [Related]
6. Comparability and biosimilarity: considerations for the healthcare provider. Lee JF; Litten JB; Grampp G Curr Med Res Opin; 2012 Jun; 28(6):1053-8. PubMed ID: 22519391 [TBL] [Abstract][Full Text] [Related]
7. The US approach to biosimilars: the long-awaited FDA approval pathway. Calvo B; Zuñiga L BioDrugs; 2012 Dec; 26(6):357-61. PubMed ID: 23030677 [TBL] [Abstract][Full Text] [Related]
8. Clinical trial development for biosimilars. Alten R; Cronstein BN Semin Arthritis Rheum; 2015 Jun; 44(6 Suppl):S2-8. PubMed ID: 26058550 [TBL] [Abstract][Full Text] [Related]
9. 'Totality of Evidence' Approach in the Development of GP2017, an Approved Adalimumab Biosimilar. Gaylis N; Both C; Lemke L; von Richter O; Yamauchi P Adv Ther; 2024 May; 41(5):1795-1814. PubMed ID: 38514505 [TBL] [Abstract][Full Text] [Related]
10. Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community. Markus R; Liu J; Ramchandani M; Landa D; Born T; Kaur P BioDrugs; 2017 Jun; 31(3):175-187. PubMed ID: 28439817 [TBL] [Abstract][Full Text] [Related]
11. Considerations in the early development of biosimilar products. Li EC; Abbas R; Jacobs IA; Yin D Drug Discov Today; 2015 May; 20 Suppl 2():1-9. PubMed ID: 25572407 [TBL] [Abstract][Full Text] [Related]
13. FDA's Approach to Regulating Biosimilars. Lemery SJ; Ricci MS; Keegan P; McKee AE; Pazdur R Clin Cancer Res; 2017 Apr; 23(8):1882-1885. PubMed ID: 28034906 [TBL] [Abstract][Full Text] [Related]
14. Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development. Cai XY; Thomas J; Cullen C; Gouty D Bioanalysis; 2012 Sep; 4(17):2169-77. PubMed ID: 23013399 [TBL] [Abstract][Full Text] [Related]
15. [Biosimilars versus original biologics. Similarities and differences from development to approval]. Windisch J Z Rheumatol; 2015 Oct; 74(8):672-81. PubMed ID: 26323591 [TBL] [Abstract][Full Text] [Related]
16. Analytic characterization of biosimilars. Sullivan PM; DiGrazia LM Am J Health Syst Pharm; 2017 Apr; 74(8):568-579. PubMed ID: 28389456 [TBL] [Abstract][Full Text] [Related]
18. Biosimilars: Key regulatory considerations and similarity assessment tools. Kirchhoff CF; Wang XM; Conlon HD; Anderson S; Ryan AM; Bose A Biotechnol Bioeng; 2017 Dec; 114(12):2696-2705. PubMed ID: 28842986 [TBL] [Abstract][Full Text] [Related]
19. Understanding Biosimilar Insulins - Development, Manufacturing, and Clinical Trials. Heinemann L; Davies M; Home P; Forst T; Vilsbøll T; Schnell O J Diabetes Sci Technol; 2023 Nov; 17(6):1649-1661. PubMed ID: 35818669 [TBL] [Abstract][Full Text] [Related]
20. Development and regulation of biosimilars: current status and future challenges. Tsiftsoglou AS; Ruiz S; Schneider CK BioDrugs; 2013 Jun; 27(3):203-11. PubMed ID: 23553340 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]