References
- U.S. Food and Drug Administratrion. What are “Biologics” questions and answers [Internet]. 2015 [cited 2016 Oct 8]. Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm.
- Epstein MS, Ehrenpreis ED, Kulkarni PM. Biosimilars: the need, the challenge, the future: the FDA perspective. Am J Gastroenterol [Internet]. 2014;109(12):1856–1859. Available from: http://www.nature.com/doifinder/10.1038/ajg.2014.151.
- Ventola CL. Biosimilars: part 1: proposed regulatory criteria for FDA approval. Pharmacy and Therapeutics [Internet]. 2013;38(5):270–287. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3737980&tool=pmcentrez&rendertype=abstract.
- Alten R, Cronstein B. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015;44:52–57. doi: https://doi.org/10.1016/j.semarthrit.2015.04.002
- GPHA. Biosimilars [Internet]. 2016 [cited 2016 Oct 8]. Available from: http://www.gphaonline.org/issues/biosimilars.
- Kesselheim AS, Tan YT, Darrow JJ, et al. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Aff. 2014;33(10):1770–1778. doi: https://doi.org/10.1377/hlthaff.2014.0529
- Grabowski HG, Guha R, Salgado M. Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future. Health Aff. 2014;33(6):1048–1057. doi: https://doi.org/10.1377/hlthaff.2013.0862
- Wish J, Charytan C, Chertow G, et al. Introduction of biosimilar therapeutics into nephrology practice in the United States. Am J Kidney Dis. 2016;68(6):843–852. doi: https://doi.org/10.1053/j.ajkd.2016.06.022
- Feldman S. Inflammatory diseases: integrating biosimilars into clinical practice. Seminars Arthritis Rheum. 2015;44:516–521. doi: https://doi.org/10.1016/j.semarthrit.2015.04.003
- Reinisch W, Smolen J. Biosimilar safety factors in clinical practice. Semin Arthritis Rheum. 2015;44:509–515.
- Warner WA, Morrison RL, Lee TY, et al. NIH public access. Lancet [Internet]. 2015;10(1):1–15. doi:10.1016/S0140-6736(14)61467-7.
- Lemery S, Estevo F, Weise M. Biosimilars: here and now. 2016.
- Socinski M, Curigliano G, Gumbiner B, et al. Clinical considerations for the development of biosimilars in oncology. MAbs. 2015;7(2):286–293. doi: https://doi.org/10.1080/19420862.2015.1008346
- Kumar R, Singh J. Biosimilar drugs: current status. Int J Appl Basic Med Res. 2014;4(2):63–66. doi: https://doi.org/10.4103/2229-516X.136774
- Macdonald J, Hartman H, Jacobs I. Regulatory considerations in oncologic biolsimilar drug development. MAbs. 2015;7(4):653–661. doi: https://doi.org/10.1080/19420862.2015.1040973
- Charles BD, Chapman MA. The physician’s perspective: a health policy brief from the institute for patient access. 2015.
- Wu J, Ezell S. How national policies impact global biopharma innovation: a worldwide ranking. Information technology and innovation foundation, 2016 [cited 2017 Nov 7]. Available from: http://www2.itif.org/2016-national-policies-global-biopharma.pdf.
- Morton F, Boller L. Enabling competition in pharmaceutical markets. Yale School of Management. 2017 [cited Nov 7]. Available from: https://www.brookings.edu/wp-content/uploads/2017/05/wp30_scottmorton_competitioninpharma1.pdf.