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Journal Abstract Search

631 related items for PubMed ID: 27813877

  • 1. Biosimilars: The US Regulatory Framework.
    Christl LA, Woodcock J, Kozlowski S.
    Annu Rev Med; 2017 Jan 14; 68():243-254. PubMed ID: 27813877
    [Abstract] [Full Text] [Related]

  • 2. The US approach to biosimilars: the long-awaited FDA approval pathway.
    Calvo B, Zuñiga L.
    BioDrugs; 2012 Dec 01; 26(6):357-61. PubMed ID: 23030677
    [Abstract] [Full Text] [Related]

  • 3. 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 Dec 01; 65(4):819-37, ii-iii. PubMed ID: 24479248
    [Abstract] [Full Text] [Related]

  • 4. A Systematic Review of U.S. Biosimilar Approvals: What Evidence Does the FDA Require and How Are Manufacturers Responding?
    Hung A, Vu Q, Mostovoy L.
    J Manag Care Spec Pharm; 2017 Dec 01; 23(12):1234-1244. PubMed ID: 29172975
    [Abstract] [Full Text] [Related]

  • 5. Biosimilars: Here and Now.
    Lemery SJ, Esteva FJ, Weise M.
    Am Soc Clin Oncol Educ Book; 2016 Dec 01; 35():e151-7. PubMed ID: 27249717
    [Abstract] [Full Text] [Related]

  • 6. FDA's Approach to Regulating Biosimilars.
    Lemery SJ, Ricci MS, Keegan P, McKee AE, Pazdur R.
    Clin Cancer Res; 2017 Apr 15; 23(8):1882-1885. PubMed ID: 28034906
    [Abstract] [Full Text] [Related]

  • 7. Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States.
    Dougherty MK, Zineh I, Christl L.
    Clin Pharmacol Ther; 2018 Jan 15; 103(1):36-38. PubMed ID: 29152721
    [Abstract] [Full Text] [Related]

  • 8. Biosimilar competition in the United States: statutory incentives, payers, and pharmacy benefit managers.
    Falit BP, Singh SC, Brennan TA.
    Health Aff (Millwood); 2015 Feb 15; 34(2):294-301. PubMed ID: 25646110
    [Abstract] [Full Text] [Related]

  • 9.
    Padda IS, Bhatt R, Parmar M.
    ; 2024 01 15. PubMed ID: 34662086
    [Abstract] [Full Text] [Related]

  • 10. The complexities of biosimilars and the regulatory approval process.
    Lucio S.
    Am J Manag Care; 2018 Jun 15; 24(11 Suppl):S231-S236. PubMed ID: 29957908
    [Abstract] [Full Text] [Related]

  • 11. Optimizing use and addressing challenges to uptake of biosimilars.
    Leber MB.
    Am J Manag Care; 2018 Nov 15; 24(21 Suppl):S457-S461. PubMed ID: 30452214
    [Abstract] [Full Text] [Related]

  • 12. The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the United States Healthcare System.
    Paradise J.
    Am J Law Med; 2015 Nov 15; 41(1):49-84. PubMed ID: 26237983
    [Abstract] [Full Text] [Related]

  • 13. Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.
    Bennett CL, Schoen MW, Hoque S, Witherspoon BJ, Aboulafia DM, Hwang CS, Ray P, Yarnold PR, Chen BK, Schooley B, Taylor MA, Wyatt MD, Hrushesky WJ, Yang YT.
    Lancet Oncol; 2020 Dec 15; 21(12):e575-e588. PubMed ID: 33271114
    [Abstract] [Full Text] [Related]

  • 14. Current market and regulatory landscape of biosimilars.
    Bhatt V.
    Am J Manag Care; 2018 Nov 15; 24(21 Suppl):S451-S456. PubMed ID: 30452213
    [Abstract] [Full Text] [Related]

  • 15. Approval Process: An Overview of Biosimilars in the Oncology Setting.
    Sowinski-Raff L.
    Clin J Oncol Nurs; 2018 Oct 01; 22(5):13-18. PubMed ID: 30239527
    [Abstract] [Full Text] [Related]

  • 16. Biosimilars in the United States: Emerging Issues in Litigation.
    Wong AY, Rumore MM, Chan AW.
    BioDrugs; 2017 Jun 01; 31(3):189-205. PubMed ID: 28424972
    [Abstract] [Full Text] [Related]

  • 17. Clinical trial development for biosimilars.
    Alten R, Cronstein BN.
    Semin Arthritis Rheum; 2015 Jun 01; 44(6 Suppl):S2-8. PubMed ID: 26058550
    [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 01; 114(12):2696-2705. PubMed ID: 28842986
    [Abstract] [Full Text] [Related]

  • 19. Development and regulation of biosimilars: current status and future challenges.
    Tsiftsoglou AS, Ruiz S, Schneider CK.
    BioDrugs; 2013 Jun 01; 27(3):203-11. PubMed ID: 23553340
    [Abstract] [Full Text] [Related]

  • 20. Frontiers in nonclinical drug development: biosimilars.
    Ryan AM.
    Vet Pathol; 2015 Mar 01; 52(2):419-26. PubMed ID: 25161206
    [Abstract] [Full Text] [Related]

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