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.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

185 related articles for article (PubMed ID: 31933227)

  • 1. Design and Analysis of Biosimilar Switching Studies.
    Chow SC; Lee SJ
    Pharmaceut Med; 2019 Oct; 33(5):379-388. PubMed ID: 31933227
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Interchangeability Of Biological Drug Products-FDA Draft Guidance.
    Endrenyi L; Markus R
    J Biopharm Stat; 2019; 29(6):1003-1010. PubMed ID: 31023141
    [TBL] [Abstract][Full Text] [Related]  

  • 3. On hybrid parallel-crossover designs for assessing drug interchangeability of biosimilar products.
    Chow SC; Song F; Cui C
    J Biopharm Stat; 2017; 27(2):265-271. PubMed ID: 28026996
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Strategies for Overcoming Barriers to Adopting Biosimilars and Achieving Goals of the Biologics Price Competition and Innovation Act: A Survey of Managed Care and Specialty Pharmacy Professionals.
    Greene L; Singh RM; Carden MJ; Pardo CO; Lichtenstein GR
    J Manag Care Spec Pharm; 2019 Aug; 25(8):904-912. PubMed ID: 31007119
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Sowing confusion in the field: the interchangeable use of biosimilar terminology.
    McKinley L; Kelton JM; Popovian R
    Curr Med Res Opin; 2019 Apr; 35(4):619-621. PubMed ID: 30556742
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 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]  

  • 7. On safety margin for drug interchangeability.
    Zheng J; Chow SC; Song F
    J Biopharm Stat; 2017; 27(2):293-307. PubMed ID: 27911675
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Biosimilar safety factors in clinical practice.
    Reinisch W; Smolen J
    Semin Arthritis Rheum; 2015 Jun; 44(6 Suppl):S9-15. PubMed ID: 26058551
    [TBL] [Abstract][Full Text] [Related]  

  • 9. 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]  

  • 10. The Science of Biosimilars-Updating Interchangeability.
    Cavazzoni P; Yim S
    JAMA; 2024 Oct; 332(15):1235-1236. PubMed ID: 39292484
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Optimizing use and addressing challenges to uptake of biosimilars.
    Leber MB
    Am J Manag Care; 2018 Nov; 24(21 Suppl):S457-S461. PubMed ID: 30452214
    [TBL] [Abstract][Full Text] [Related]  

  • 12. 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. Biosimilars: The US Regulatory Framework.
    Christl LA; Woodcock J; Kozlowski S
    Annu Rev Med; 2017 Jan; 68():243-254. PubMed ID: 27813877
    [TBL] [Abstract][Full Text] [Related]  

  • 14. 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]  

  • 15. Regulation of biosimilar medicines and current perspectives on interchangeability and policy.
    O'Callaghan J; Barry SP; Bermingham M; Morris JM; Griffin BT
    Eur J Clin Pharmacol; 2019 Jan; 75(1):1-11. PubMed ID: 30187103
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Biosimilars: Here and Now.
    Lemery SJ; Esteva FJ; Weise M
    Am Soc Clin Oncol Educ Book; 2016; 35():e151-7. PubMed ID: 27249717
    [TBL] [Abstract][Full Text] [Related]  

  • 17. White paper: an outlook on U.S. biosimilar competition.
    Bourgoin AF; Nuskey B
    Drugs Today (Barc); 2013 Jun; 49(6):399-410. PubMed ID: 23807943
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Sample Size for Biosimilar Trials: In Defense of Synthesis.
    Clark T; Jo SJ; Phillips A
    Ther Innov Regul Sci; 2018 May; 52(3):300-305. PubMed ID: 29714537
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Monoclonal Antibody Biosimilars in Oncology: Critical Appraisal of Available Data on Switching.
    Declerck P; Bakalos G; Zintzaras E; Barton B; Schreitmüller T
    Clin Ther; 2018 May; 40(5):798-809.e2. PubMed ID: 29699853
    [TBL] [Abstract][Full Text] [Related]  

  • 20. The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond.
    Chang LC
    J Food Drug Anal; 2019 Jul; 27(3):671-678. PubMed ID: 31324283
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.