Knowledge, Attitude and Practice on Biologicals and Biosimilars among Clinicians in Radiotherapy Department
Background: The decoding of human genome helped to design pharmacological agents like Biologicals and Biosimilars which can target the affected etiological aberrations. Biological agents are large complex molecules produced by recombinant techniques in a living system for therapeutic or diagnostic uses and have revolutionized treatment of many diseases. Patent expiry of Biologicals has led to the development of Biosimilars which are similar in efficacy & safety and have no clinically meaningful differences, but are not identical to Biologicals and undergo fewer clinical trials than their reference biologicals. Clinicians’ in- depth knowledge of these agents is important to optimize the use of cost-effective & easily accessible options. Methods: This is a cross sectional observational study conducted between Feb-March 2020 in Radiotherapy/Chemotherapy Oncology Department of Dr B.R.A.M. Hospital & Pt. J. N. M. Medical College, Raipur, Chhattisgarh, using a self-administered, structured questionnaire consisting of 15-question among 30 clinicians prescribing Biologicals and Biosimilars. Results: 83.3% of clinicians were familiar with the term ‘Biologicals’ & ‘Biosimilars’. 60% believed that Biosimilars are same as Generic Medicines and have the same potency as Biologicals. 53% assumed that Biologicals & Biosimilars can be switched. 50% were able to explain the difference or similarity between Biologicals and Biosimilars. Conclusion: The findings reveal that the clinicians had good knowledge about Biologicals and Biosimilars but lacked application of this knowledge in clinical practice. This highlights a need for regular educational initiative to reduce the knowledge deficit & its application in clinical practice. Further, there must be a National Treatment Guidelines on use of Biologicals and Biosimilars.
2.Giuliani R, Tabernero J, Cardoso F, McGregor KH, Vyas M, De Vries EG. Knowledge and use of biosimilars in oncology: a survey by the European Society for Medical Oncology. ESMO open. 2019;4(2):e000460.
3.World Health Organisation. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs). WHO Expert Committee on Biological Standardization, Sixtieth report (19-23 October 2009) WHO Technical Report Series (2013) No. 977, - (2013) Annex 2. Accessed from: https://www.who.int/publications/m/item/sbp-trs-977- Annex-2
4.Biological Drugs: Dictionary. U. S. National Institutes of Health, National Cancer Institute. Accessed from: https://www.cancer.gov/publications/dictionaries/cancer- terms/def/biological-drug. Accessed 19 Jul 2021
5.US Food and Drug Administration. Title VII— improving access to innovative medical therapies. Retrieved from: https://www.fda.gov/drugs/biosimilars/biosimilar-and- interchangeable-products#reference Accessed 15 Aug 2021
6.Pooja Paul, Harvinder Popoli, Ankit Saxena, Anamika Jaiswal, Sudha Sah. Current scenario of biosimilar. Pharma Innovation. 2018;7(7):188-193.
7.Lu U. Biologics price competition and innovation act: Striking a delicate balance between innovation and accessibility. Minn JL Sci Tech. 2014;15:613.
8.Rushvi P, Charmy K, Nirav C, Narendra C. Biosimilars: an emerging market opportunities in India. Pharmaceut Reg Affairs. 2016;5(1):1-7.
8.Agrawal M, Todar T, Hishikar R, Joshi U, Singh P. Sketchy knowledge skeptical attitude towards generic and branded drugs. Indian J Pharm Pharmacol. 2016;3(4):214-220.
9.Meher BR, Balan S, Mohanty RR, Jena M, Das S. Biosimilars in India; current status and future perspectives. Journal of Pharmacy & Bioallied Sciences. 2019;11(1):12.
10.Pagani E. Why are biosimilars much more complex than generics?. Einstein (São Paulo). 2019 ;17(1):eED4836.
11.Blackstone EA, Joseph PF. The economics of biosimilars. American Health & Drug Benefits. 2013;6(8):469.
12.Hu Y, Song Z, Jiang D, Zhuo L, Cheng Y, Zhao R. Knowledge, attitudes and practice of healthcare providers, healthcare regulatory practitioners and patients toward biosimilars in China: insights from a nationwide survey. Front Pharmacol. 2022:2053.
13.Karateev D, Belokoneva N. Evaluation of physicians’ knowledge and attitudes towards biosimilars in Russia and issues associated with their prescribing. Biomolecules. 2019;9(2):57.
14.Shraim NY, Al Taha TA, Qawasmeh RF, et al. Knowledge, attitudes and practices of community pharmacists on generic medicines in Palestine: a cross-sectional study. BMC Health Serv Res. 2017;17(1):1-9.
15.Chapman SR, Fitzpatrick RW, Aladul MI. Knowledge, attitude and practice of healthcare professionals towards infliximab and insulin glargine biosimilars: result of a UK web-based survey. BMJ Open. 2017;7(6):e016730.
16.Park SK, Moon W, Kim ES, Park SH, Park DI. Knowledge and viewpoints on biosimilar monoclonal antibodies among Asian physicians: comparison with European physicians. The Korean Journal of Gastroenterology. 2019;74(6):333-40.
17.Shakeel S, Hassali MA, Rehman H, ur Rehman A, Muneswarao J. Knowledge, attitude, and practice towards biosimilars and interchangeable products: a prescriptive insight by the pharmacists. Int J Gen Med. 2020;13:1075.
18.Heled Y. Why primary patents covering biologics should be unforceable against generic applicants under the Biologics Price Competition and Innovation Act. Annals Health L. 2012;21:211.
19.Niazi SK. The Coming of Age of Biosimilars: A Personal Perspective. Biologics. 2022;2(2):107-27.
20.Maksabedian Hernandez EJ, Graf M, Portelli A, Shafrin J. Estimating the impact of biosimilar entry on prices and expenditures in rheumatoid arthritis: a case study of targeted immune modulators. Journal of Medical Economics. 2022;25(1):1118- 26.
21.Cohen H, Beydoun D, Chien D, et al. Awareness, knowledge, and perceptions of biosimilars among specialty physicians. Adv Ther. 2016;33(12):2160-72.
22.Barlas S. FDA guidance on biosimilar interchangeability elicits diverse views: current and potential marketers complain about too-high hurdles. Pharm Ther. 2017;42(8):509.
23.Singh P, Desai PN, Dutta V. Rising biosimilars in the Indian biopharmaceutical industry: emerging challenges and way forward. Technology Analysis & Strategic Management. 2021:1-6.
24.European Medicines Agency. Guideline on good pharmacovigilance practices (GVP). Product- or population-specific considerations II: biological medicinal products.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/ 08/WC500211728.pdf. (2016). Accessed September 28, 2018.
25.Jacobs I, Singh E, Sewell KL, Ahmad AS, Shane LG. Patient attitudes and understanding about biosimilars: an international cross-sectional survey. Patient Preference and Adherence. 2016;10:937.
26.Robertson JS. The challenges of nomenclature-INN, biosimilars and biological qualifiers. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(3):110-2.
|Issue||Vol 11, No 2 (Spring 2023)|
|Biologicals; Biosimilars; Knowledge; Attitude; Practice|
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