Main Article Content
Abstract
Biosimilars are considered to be one of the solutions to combat the substantially increasing costs of cancer treatment and its imminent introduction is expected to expand affordability worldwide. Biosimilars were developed as copies of original products that were themselves copies/better biosimilars of natural proteins.
Objectives
To review the drug utilization and Quality of life of biosimilars used in oncology patients.
Methods
It was a Hospital based observational, prospective study conducted by random selection of 50 patients. The data was collected regarding demographic details of the patient, chemotherapeutic drugs and administration,diagnosis, laboratory tests, mammography, PET (positron emission tomography), present complaints, history of patients and QOL of patients were also recorded. Patients were included in the study after obtaining verbal informed consent.
Results and discussion
In this prospective observational study the drug utilization review of biosimilars in various types of cancers were evaluated in a total of 50 patients.Among 50 patients who were treated with biosimilars and chemotherapeutics, 22% were male and 78% were female. The mean total scores for breast cancer, lung cancer, melanoma,NHL ,HL Urothelial carcinoma and colon cancer subjects at final visit increased compared to initial visit. This increment was highly significant statistically and the values were found to be [t= 30.9487, p= 0.0001] at 95% confidence interval.
Conclusion
All biosimilars showed improvement in symptoms &QOL scores. During the study period it was revealed that the most commonly used biosimilars for breast cancer was Trastuzumab, lung cancer durvalumab, melanoma &hodgkin’s lymphoma &urothelial carcinoma & colon cancer nivolumab, non-hodgkin’s lymphoma rituximab. The maximum improvement in QOL was obtained with nivolumab in urothelial cancer, melanoma &Hodgkin’s lymphoma patients.
Keywords
Article Details
References
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References
[1]. Abraham J: Developing oncology biosimilars: An essential approach for the future. SeminOncol 40, 2013, S5-S24, Crossref, Medline, Google Scholar
[2]. Zelenetz AD, Ahmed I, Braud EL, et al: NCCN biosimilars white paper: Regulatory, scientific, and patient safety perspectives. J NatlComprCancNetw 9, 2011, S1-S22,Crossref, Medline, Google Scholar
[3]. Azzoli CG, Giaccone G, Temin S: American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J OncolPract 6, 2010, 39-43, Link, Google Scholar
[4]. Liang SY, Haas JS, Phillips KA: Medicare formulary coverage for top-selling biologics. Nat Biotechnol 27, 2009, 1082-1084, Crossref, Medline, Google Scholar
[5]. Doloresco F, Fominaya C, Schumock GT, et al: Projecting future drug expenditures: 2011. Am J Health Syst Pharm 68, 2011, 921-932, Crossref, Medline, Google Scholar
[6]. Bevacizumabprescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125085s263lbl.pdf Google Scholar
[7]. Rituximabprescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5311lbl.pdf Google Scholar
[8]. Trastuzumabprescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/trasgen020900lb.htm Google Scholar
[9]. Müller R, Renner C, Gabay C, et al: The advent of biosimilars: Challenges and risks. Swiss Med Wkly 144:w13980, 2014 Medline, Google Scholar
[10]. Niederwieser D, Schmitz S: Biosimilar agents in oncology/haematology: From approval to practice. Eur J Haematol 86, 2011, 277-288, Crossref, Medline, Google Scholar
[11]. Nahon S, Rastkhah M, Ben Abdelghani M, et al: Zarzio, biosimilar of filgrastim, in prophylaxis of chemotherapy-induced neutropenia in routine practice: A French prospective multicentric study. Support Care Cancer 24, 2016, 1991-1998, Crossref, Medline, Google Scholar
[12]. Beck A, Reichert JM: Approval of the first biosimilar antibodies in Europe: A major landmark for the biopharmaceutical industry. MAbs 5, 2013, 621-623, Crossref, Medline, Google Scholar
[13]. https://www.graphpad.com/quickcalcs/ttest1.cfm web based statistical calculator.