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Abstract

Biosimilar medicines are biologic treatments that are clinically equivalent to a previously approved reference biological product in terms of quality, efficacy, safety, and immunogenicity, and have the potential to lower biologic costs. Given the growing number of oncology biosimilars, it is critical to quantify the economic impact of biosimilars in oncology, using trastuzumab and rituximab as examples, which have the highest budgetary impact in Oncology Units, respectively. Biologics are important in cancer treatment not only because of their therapeutic effects and ability to improve outcomes, but also because they are supportive care agents. These are more difficult to make and take longer to get to market. Because biologics are much more expensive than small-molecule medications, their usage has put a growing economic strain on healthcare systems around the world. Biosimilars are intended to be substantially similar to existing branded biologics, but because biologics cannot be precisely duplicated, they should not be referred to as generic, exact copies of the originator biologic. As patent protection for some of the most extensively used biologics begins to expire, biosimilars have the potential to enhance access and give lower-cost options for cancer treatment.

Keywords

biologics growing potential systems

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How to Cite
Abdul Jamsheer P.K, Vigneshwaran.L.V, Senthil Kumar.M, & Senthil Kumar.M. (2022). Biosimilar in Oncology. Texas Journal of Multidisciplinary Studies, 7, 145–151. Retrieved from https://zienjournals.com/index.php/tjm/article/view/1259

References

  1. Zelenetz AD, Ahmed I, Braud EL, Cross JD, Davenport-Ennis N, Dickinson BD, Goldberg SE, Gottlieb S, Johnson PE, Lyman GH, Markus R. NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives. Journal of the National Comprehensive Cancer Network. 2011 Sep 1;9(Suppl_4):S-1.
  2. Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Targ Oncol. 2012;7(Suppl 1): S57–67.
  3. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. New England journal of medicine. 2004 Jun 3;350(23):2335-42.
  4. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. New England journal of medicine. 2001 Mar 15;344(11):783-92.
  5. Schellekens H. Follow-on biologics: challenges of the ‘next generation’. Nephrology Dialysis Transplantation. 2005 May 1;20(suppl_4):iv31-6.
  6. Belsey MJ, Harris LM, Das RR, Chertkow J. Biosimilars: initial excitement gives way to reality. Nature Reviews Drug Discovery. 2006 Jul 1;5(7):535-6.
  7. Kozlowski S, Woodcock J, Midthun K, Behrman Sherman R. Developing the nation's biosimilars sprogram. New England Journal of Medicine. 2011 Aug 4;365(5):385-8.
  8. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009. Abgerufen unter: https://www. who. int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2. pdf. 2018.
  9. Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, Gravanis I, Heim HK, Heinonen E, Ho K, Moreau A. Biosimilars: what clinicians should know. Blood, The Journal of the American Society of Hematology. 2012 Dec 20;120(26):5111-7.
  10. Schellekens H. The first biosimilar epoetin: but how similar is it?. Clinical journal of the American Society of Nephrology. 2008 Jan 1;3(1):174-8.
  11. Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrology Dialysis Transplantation. 2006 Oct 1;21(suppl_5):v13-6. Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrology Dialysis Transplantation. 2006 Oct 1;21(suppl_5):v13- 6.v
  12. sGuideline IH. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. S6 (R1). ICH Steering Committee, Step. 1997;4.
  13. Evans SJ, Day SJ. M edicines and H ealthcare P roducts R egulatory A gency (MHRA)(Formerly MCA). Encyclopedia of Biostatistics. 2005 Jul 15;5.
  14. Buske C, Ogura M, Kwon HC, Yoon SW. An introduction to biosimilar cancer therapeutics: definitions, rationale for development and regulatory requirements. Future Oncology. 2017 Jun;13(15s):5-16.
  15. Waller CF, Friganović A. Biosimilars in oncology: Key role of nurses in patient education. Future Oncology. 2020 Sep;16(25):1931-9.
  16. Cornes P, Aapro M. The impact of biosimilars in supportive care in cancer. Eur Oncol Haematol. 2018 Feb 22;14(1):20-32.
  17. Gascón P, Tesch H, Verpoort K, Rosati MS, Salesi N, Agrawal S, Wilking N, Barker H, Muenzberg M, Turner M. Clinical experience with Zarzio® in Europe: what have we learned?. Supportive Care in Cancer. 2013 Oct;21(10):2925-32
  18. Cornes P, Aapro M. The impact of biosimilars in supportive care in cancer. Eur Oncol Haematol. 2018 Feb 22;14(1):20-32.
  19. Waller CF, Semiglazov VF, Tjulandin S, Bentsion D, Chan S, Challand R. A phase III randomized equivalence study of biosimilar filgrastim versus Amgen filgrastim in patients receiving myelosuppressive chemotherapy for breast cancer. Oncology Research and Treatment. 2010;33(10):504-11.
  20. European Commission. The impact of biosimilar competition on price, volume and market share – update 2017. (2017). www.ec.europa.eu/growth/content/impact-biosimilar- competition-price-volume-and-market-share-update-2017 en.
  21. Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD. American Society of Clinical Oncology statement: biosimilars in oncology. Journal of Clinical Oncology. 2018 Apr 20;36(12):1260-5.
  22. Gottlieb S. Don't Give Up on Biosimilars—Congress Can Give Them a Boost: Drugs grown in live cells are hard to replicate. But policy changes can help accelerate the process. American Health & Drug Benefits. 2019 Sep;12(5):252.
  23. Jackisch C, Scappaticci FA, Heinzmann D, Bisordi F, Schreitmüller T, Minckwitz GV, Cortés J. Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation. Future Oncology. 2015 Jan;11(1):61-71. Jackisch C, Scappaticci FA, Heinzmann D, Bisordi F, Schreitmüller T, Minckwitz GV, Cortés J. Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation. Future Oncology. 2015 Jan;11(1):61-71.
  24. Burzykowski, T., Buyse, M., Piccart-Gebhart, M.J., Sledge, G., Carmichael, J., Luck, H.J., Mackey, J.R., Nabholtz, J.M., Paridaens, R., Biganzoli, L. and Jassem, J., 2008. Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer. Journal of Clinical Oncology, 26(12), pp.1987-1992.
  25. Tkaczuk KH, Jacobs IA. Biosimilars in oncology: from development to clinical practice. InSeminars in oncology 2014 Apr 1 (Vol. 41, pp. S3-S12). WB Saunders.
  26. Pivot X, Aulagner G, Blay JY, Fumoleau P, Kaliski A, Sarkozy F, Limat S. Challenges in the
  27. implementation of trastuzumab biosimilars: an expert panel’s recommendations. Anti-cancer drugs. 2015 Nov 1;26(10):1009-16.