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.
755 related articles for article (PubMed ID: 25572407)
1. 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]
2. Key considerations in the preclinical development of biosimilars. Bui LA; Hurst S; Finch GL; Ingram B; Jacobs IA; Kirchhoff CF; Ng CK; Ryan AM Drug Discov Today; 2015 May; 20 Suppl 1():3-15. PubMed ID: 25912284 [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. Clinical data and regulatory issues of biosimilar products. Stevenson JG Am J Manag Care; 2015 Dec; 21(16 Suppl):s320-30. PubMed ID: 26788808 [TBL] [Abstract][Full Text] [Related]
7. Biosimilar monoclonal antibodies: preclinical and clinical development aspects. Gonçalves J; Araújo F; Cutolo M; Fonseca JE Clin Exp Rheumatol; 2016; 34(4):698-705. PubMed ID: 27383278 [TBL] [Abstract][Full Text] [Related]
8. Biosimilars: Rationale and current regulatory landscape. Olech E Semin Arthritis Rheum; 2016 Apr; 45(5 Suppl):S1-10. PubMed ID: 26947438 [TBL] [Abstract][Full Text] [Related]
9. Clinical development and trial design of biosimilar products: a Japanese perspective. Nagasaki M; Ando Y J Biopharm Stat; 2014; 24(6):1165-72. PubMed ID: 25033370 [TBL] [Abstract][Full Text] [Related]
10. Biosimilars battle rages on, Amgen fights both sides. Senior M Nat Biotechnol; 2013 Apr; 31(4):269-70. PubMed ID: 23563402 [No Abstract] [Full Text] [Related]
11. [Regulatory aspects of biosimilars. Myths and facts]. Schneider CK; Weise M Z Rheumatol; 2015 Oct; 74(8):695-700. PubMed ID: 26385104 [TBL] [Abstract][Full Text] [Related]
12. Global regulatory standards for the approval of biosimilars. Mounho B; Phillips A; Holcombe K; Grampp G; Lubiniecki T; Mollerup I; Jones C Food Drug Law J; 2010; 65(4):819-37, ii-iii. PubMed ID: 24479248 [TBL] [Abstract][Full Text] [Related]
15. 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]
16. A consistency approach for evaluation of biosimilar products. Tsou HH; Chang WJ; Hwang WS; Lai YH J Biopharm Stat; 2013; 23(5):1054-66. PubMed ID: 23957515 [TBL] [Abstract][Full Text] [Related]
17. 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. Low-molecular-weight heparin biosimilars: potential implications for clinical practice. Australian Low-Molecular-Weight Heparin Biosimilar Working Group (ALBW). Nandurkar H; Chong B; Salem H; Gallus A; Ferro V; McKinnon R; Intern Med J; 2014 May; 44(5):497-500. PubMed ID: 24816308 [TBL] [Abstract][Full Text] [Related]
19. Considerations related to comparative clinical studies for biosimilars. Rathore AS; Stevenson JG; Chhabra H Expert Opin Drug Saf; 2021 Mar; 20(3):265-274. PubMed ID: 33455482 [No Abstract] [Full Text] [Related]
20. Biosimilar competition in the United States: statutory incentives, payers, and pharmacy benefit managers. Falit BP; Singh SC; Brennan TA Health Aff (Millwood); 2015 Feb; 34(2):294-301. PubMed ID: 25646110 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]