International Journal of Pharma and Bio Sciences
 
 
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REVIEW ARTICLE
Int J Pharm Bio Sci Volume 13 Issue 4, October - December, Pages:46-56

Unravelling The Potentials of Biosimilars In Cancer Therapeutics: A Concise Review

Bharathi Tumkur Ramasetty and Narashima Prasad K
DOI: http://dx.doi.org/10.22376/Ijpbs.2022.13.4.p46-56
Abstract:

Cancer is a serious health issue in all developed countries, and it is second reason of bereavement generally related with people ageing and lifestyle. According to International research in globe on cancer the burden is expected to be 28.4 million cases in 2040. Hence it is important to reduce the cancer burden in the globe by developing innovative treatment options, but many of the today’s most novel diagnostic tools, including molecular typing, have empowered improvements in various cancer therapies with better clinical results with high survival rate. But these treatments are of highly expensive and their exclusive rights are estimated to terminate in few years which affects several patients to access better treatment. With increase in cancer health care cost several strategies have been prioritized by united states and around world leading to the development of biosimilars, which have similar biological  activity compared to their innovator drug and are often most cost effective and helps the patients to get better treatment and it is considered as a potential solution for cancer therapy. Hence the current review aims to provide a rationalised report on development of biosimilar drugs approved for cancer therapeutics, their economics, regulatory framework, benefits, risks, challenges, major industries involved, quality, safety and efficacy in cancer therapeutics across the globe is discussed.

Keywords: Biosimilars, Cancer Therapy, Innovators, Quality, Safety, Efficacy, Regulatory
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REFERENCES

 

Peeters M, Planchard D, Pegram M, Gonçalves J, Bocquet F, Jang H. Biosimilars in an era of rising oncology treatment options. Future Oncol. 2021;17(29):3881-92. doi: 10.2217/fon-2021-0546, PMID 34189937.

2.       Business standard [3rd FEB, 2014]. Available from: https://investor.mylan.com/news-releases/news-release-details/mylan-launches-first-trastuzumab-biosimilar-hertraztm-india 2014. Mylan Inc.

3.       Ngo D, Chen J. A clinical review of biosimilars approved in oncology. Ann Pharmacother. 2021;55(3):362-77. doi: 10.1177/1060028020944596, PMID 32715722.

4.       Konstantinidou S, Papaspiliou A, Kokkotou E. Current and future roles of biosimilars in oncology practice. Oncol Lett. 2020;19(1):45-51. doi: 10.3892/ol.2019.11105, PMID 31897113.

5.       Santos SB, Sousa Lobo JM, Silva AC. Biosimilar medicines used for cancer therapy in Europe: a review. Drug Discov Today. 2019;24(1):293-9. doi: 10.1016/j.drudis.2018.09.011, PMID 30244082.

6.       Taylor R; 2021. Available from: https://www.aao.org/eyenet/article/biosimilars-in-ophthalmology [cited 15.9.2022].

7.       Kabir ER, Moreino SS, Sharif Siam MK. The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy. Biomolecules. 2019;9(9):410. doi: 10.3390/biom9090410, PMID 31450637.

8.       Oncology Biosimiliar market [cited September 15, 2022]. Available from: https://www.fortunebusinessinsights.com/industry-reports/oncology-biosimilars-market-100578-2022.

9.       Chopra R, Lopes G. Improving access to cancer treatments: the role of biosimilars. J Glob Oncol. 2017;3(5):596-610. doi: 10.1200/JGO.2016.008607, PMID 29094099.

10.     Inotai A, Csanadi M, Petrova G, Dimitrova M, Bochenek T, Tesar T et al. Patient access, unmet medical need, expected benefits, and concerns related to the utilisation of biosimilars in Eastern European countries: a survey of experts. BioMed Res Int. 2018;2018:9597362. doi: 10.1155/2018/9597362, PMID 29546072.

11.     Nahleh Z, Lyman GH, Schilsky RL, Peterson DE, Tagawa ST, Chavez-MacGregor M et al. Use of biosimilar medications in oncology. JCO Oncol Pract. 2022;18(3):177-86. doi: 10.1200/OP.21.00771, PMID 35041524.

12.     Casak SJ, Lemery SJ, Chung J, Fuchs C, Schrieber SJ, Chow ECY et al. FDA’s approval of the first biosimilar to BevacizumabFDA. Clin Cancer Res. 2018 Sep 15;24(18):4365-70. doi: 10.1158/1078-0432.CCR-18-0566, PMID 29743182.

13.     Biosimilar product information; Updated Feb 25 2022. FDA [cited Jul 12, 2022]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Along with the List of FDA approved Biosimilars used in cancer treatment. Available from: https://www.cancer.org/treatment/treatments-and-side-effects/treatmenttypes/biosimilar-drugs/list.html.

14.     Amgen and Allergan’s MVASI™ (bevacizumab-awwb) and KANJINTI™ (trastuzumab-anns) Now available in the United States [Media Release]. htt ps:. Available from: http://www.amgen.com/newsroom/press-releases/2019/07/amgen-and-allerga ns-mvasi-bevacizumabawwb-and-kanjinti-trastuzumabanns-now-available-in-th e-united-states [accessed 17.7.22].

15.     Generics and Biosimilars Initiative (GaBI) Online Biosimilars approved in Europe [Media Release]; 2021. Available from: https://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe [accessed 17.7.22].

16.     Generics and Biosimilars Initiative (GaBI) Online Biosimilars approved in the US [Media Release]; 2015. Available from: https://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US [accessed 17.7.22].

17.     Ditani AS, Mallick PP, Anup N, Tambe V, Polaka S, Sengupta P et al. Biosimilars accessible in the market for the treatment of cancer. J Control Release. 2021;336(336):112-29. doi: 10.1016/j.jconrel.2021.06.014, PMID 34126171.

18.     Zhang Y, Brar N, Shaikh SA, Fajardo D, Feng X. Frontiers in biopharmaceutical development of biologics and biosimilars: opportunities and challenges. Biol Biosimilars. 2022:21-32.

19.     Engelbak Nielsen Z, Eriksson S, Schram Harsløf LB, Petri S, Helgesson G, Mangset M et al. Are cancer patients better off if they participate in clinical trials? A mixed methods study. BMC Cancer. 2020;20(1):401. doi: 10.1186/s12885-020-06916-z, PMID 32384883.

20.     Kaur H. Characterization of glycosylation in monoclonal antibodies and its importance in therapeutic antibody development. Crit Rev Biotechnol, 17. 2021;41(2):300-15. doi: 10.1080/07388551.2020.1869684, PMID 33430641.

21.     Ebbers HC, Crow SA, Vulto AG, Schellekens H. Interchangeability, immunogenicity and biosimilars. Nat Biotechnol. 2012;30(12):1186-90. doi: 10.1038/nbt.2438, PMID 23222784.

22.     Mellstedt H, Niederwieser D, Ludwig H. The Challenge of biosimilars. Ann Oncol. 2008;19(3):411-9. doi: 10.1093/annonc/mdm345.

23.     Tripathi NK, Shrivastava A. Scale up of biopharmaceuticals production. In: Nanoscale fabrication, optimization, scale-up and biological aspects of pharmaceutical nanotechnology William Andrew Publishing, Jan 1; 2018. p. 133-72.

24.     Bee JS, Randolph TW, Carpenter JF, Bishop SM, Dimitrova MN. Effects of surfaces and leachables on the stability of biopharmaceuticals. J Pharm Sci. 2011;100(10):4158-70. doi: 10.1002/jps.22597, PMID 21523787.

25.     Bhairav BA, Saudagar RB, Gondhkar SB, Dipak MD, Neha VN. Biosimilars: global scenario and challenges. Int J Biopharm. 2014;5(1):19-28.

26.     Yuan J, Wenyan Xue WW, Poon HF. Analytical approach for biosimilar development: special focus on monoclonal antibody biosimilars. Int J Biopharm Sci. 2018;1(2):1-4. doi: 10.31021/ijbs.20181109.

27.     Khraishi M, Stead D, Lukas M, Scotte F, Schmid H. Biosimilars: a multidisciplinary perspective. Clin Ther. 2016;38(5):1238-49. doi: 10.1016/j.clinthera.2016.02.023, PMID 26988243.

28.     United States Food Drug Administration. Biosimilar development [review], and approval. Published October 20, 2017. 2020. Google Scholar.

29.     Mohit kulmi power point presentation on biopharmaceuticals and biosimilar drugs from SAIMS, Indore dept of pharmacology accessed in slideshare on 6th Aug 2022. a scribed company. Available from: https://www.slideshare.net/macrock707/biopharmaceuticals-and-biosimilar-drugs.

30.     Oncology Biosimiliar market [cited September 15, 2022]. Available from: https://www.fortunebusinessinsights.com/industry-reports/oncology-biosimilars-market-100578-2022.

31.     US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER); 2015 Apr 28.

32.     Sadek MAZ. Global status of biosimilars and its influential factors. Eur J Bus Manag Research. 2020;5(6). doi: 10.24018/ejbmr.2020.5.6.565.

33.     Golshani S, Ali Faramarzi MA. Expected impact of biosimilars on the pharmaceutical companies. Iran J Med Sci. 2021;46(5):399-401. doi: 10.30476/IJMS.2021.92314.2356, PMID 34539015.

34.     Liu Y. Utilizing oncology biosimilars to minimize the economic burden associated with cancer treatment: managed care considerations. Am J Manag Care. 2021;27(14);Suppl. doi: 10.37765/ajmc.2021.88734, PMID 34403576.

35.     Coiffier B. Preparing for a new generation of biologic therapies: understanding the development and potential of biosimilar cancer therapeutics. Future Oncol. 2017;13(15s):1-3. doi: 10.2217/fon-2017-0157, PMID 28482698.

36.     Zieli?ska J, Bialik W. Recent changes on the biopharmaceutical market after the introduction of biosimilar G-CSF products. Oncol Clin Pract. 2016;12(4):144-52.

37.     Soni GR. Overview of non-innovator biological products in India. GaBI J. 2020;1:9(1).

38.     Lemery SJ, Ricci MS, Keegan P, McKee AE, Pazdur R. FDA’s approach to regulating biosimilars FDA’s approach to regulating biosimilars. Clin Cancer Res, 15. 2017;23(8):1882-5.

39.     Brennan Z. Regulatory explainer: everything you need to know about biosimilars. Focus/news-articles/2016/8/regulatory-explainer-everything-you-need-to-know-about-biosimilars. Org/regulatory. Regulatory Affairs Professional Society Retrieved from: https://www. raps; 2018.

40.     Kirchhoff CF, Wang XM, Conlon HD, Anderson S, Ryan AM, Bose A. Biosimilars: key regulatory considerations and similarity assessment tools. Biotechnol Bioeng. 2017;114(12):2696-705. doi: 10.1002/bit.26438, PMID 28842986.

41.     Jensen AR. US FDA proposals for naming of BioLogicals and labelling of biosimilars. Generics Biosimilars Initiat J,1. 2016;5(3):140-4.

42.     Robinson JC, Jarrion Q. Competition from Biosimilars Drives Price Reductions for Biologics in the French Single-Payer Health System: study examines biosimilar prices in the French single-payer health system. Health Aff. 2021;40(8):1190-7. doi: 10.1377/hlthaff.2021.00070.

43.     Batel R. Biosimilar’s growth in Pharmerging markets: an analysis of the regulatory environments; 2020.

44.     Thill M, Thatcher N, Hanes V, Lyman GH. Biosimilars: what the oncologist should know. Future Oncol. 2019;15(10):1147-65. doi: 10.2217/fon-2018-0728, PMID 30793950.

 

45.      Umesha  S and Shivakumar J.  bacterial quoroum sensing and its applications in Biotechnology. Int J Pharm Bio Sci. 2013: 4(2); 850-861.

 

 

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