Volume and trends of adalimumab and pembrolizumab reimbursed market: the Bulgarian perspective

References

• Overview of therapeutic monoclonal antibodies. Available online: https://www.uptodate.com/contents/overview-of-therapeutic-monoclonal-antibodies/print.
   Google Scholar
• Berger M, Shankar V, Vafai A. Therapeutic applications of monoclonal antibodies. Am J Med Sci. 2002;324(1):14–30.
   PubMed Web of Science ®Google Scholar
• Singh S, Kumar NK, Dwiwedi P, et al. Monoclonal antibodies: a review. Curr Clin Pharmacol. 2018;13(2):85–99.
   PubMed Web of Science ®Google Scholar
• Jahanshahlu L, Rezaei N. Monoclonal antibody as a potential anti-COVID-19. Biomed Pharmacother. 2020;129:110337.
   PubMed Web of Science ®Google Scholar
• Shanmugaraj B, Siriwattananon K, Wangkanont K, et al. Perspectives on monoclonal antibody therapy as potential therapeutic intervention for coronavirus disease-19 (COVID-19)). Asian Pac J Allergy Immunol. 2020;38(1):10–18.
   PubMed Web of Science ®Google Scholar
• Weiner GJ. Building better monoclonal antibody-based therapeutics. Nat Rev Cancer. 2015;15(6):361–370.
   PubMed Web of Science ®Google Scholar
• Nissim A, Chernajovsky Y. Historical development of monoclonal antibody therapeutics. Handb Exp Pharmacol. 2008;(181):3–18.
   PubMedGoogle Scholar
• Corren J, Castro M, Chanez P, et al. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019;122(1):41–49.e2.
   PubMed Web of Science ®Google Scholar
• Weisel K, Ludwig H, Rieth A, et al. Health-related quality of life of carfilzomib- and daratumumab-based therapies in patients with relapsed/refractory multiple myeloma, based on german benefit assessment data. Qual Life Res. 2020;29(1):69–79.
   PubMed Web of Science ®Google Scholar
• Mazieres J, Kowalski D, Luft A, et al. Health-related quality of life with carboplatin-paclitaxel or nab-paclitaxel with or without pembrolizumab in patients with metastatic squamous non-small-cell lung cancer. J Clin Oncol. 2020;38(3):271–280.
   PubMed Web of Science ®Google Scholar
• Spigel DR, McCleod M, Jotte RM, et al. Safety, efficacy, and patient-reported health-related quality of life and symptom burden with nivolumab in patients with advanced non-small cell lung cancer, including patients aged 70 years or older or with poor performance status (CheckMate 153)). J Thorac Oncol. 2019;14(9):1628–1639.
   PubMed Web of Science ®Google Scholar
• Vaughn DJ, Bellmunt J, Fradet Y, et al. Health-related quality-of-life analysis from KEYNOTE-045: a phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer. J Clin Oncol. 2018;36(16):1579–1587.
   PubMed Web of Science ®Google Scholar
• Agache I, Beltran J, Akdis C, et al. Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI guidelines – recommendations on the use of biologicals in severe asthma. Allergy. 2020;75(5):1023–1042.
   PubMed Web of Science ®Google Scholar
• Lu RM, Hwang YC, Liu IJ, et al. Development of therapeutic antibodies for the treatment of diseases. J Biomed Sci. 2020;27(1).
   Web of Science ®Google Scholar
• Liu JK. The history of monoclonal antibody development – progress, remaining challenges and future innovations. Ann Med Surg (Lond)). 2014;3(4):113–116.
   PubMedGoogle Scholar
• Kaplon H, Reichert JM. Antibodies to watch in 2019. MAbs. 2019;11(2):219–238.
   PubMed Web of Science ®Google Scholar
• Biot J, Fasano C, Dos Santos C. D’orthoclone au dénosumab: l’expansion des anticorps monoclonaux à des fins thérapeutiques [from orthoclone to denosumab, the fast growing market of monoclonal antibodies]. Med Sci (Paris)). 2009;25(12):1177–1182. PMID: 20035702.
   PubMed Web of Science ®Google Scholar
• Moorkens E, Jonker-Exler C, Huys I, et al. Overcoming barriers to the market access of biosimilars in the European union: the case of biosimilar monoclonal antibodies. Front Pharmacol. 2016;7(7):193.
   PubMed Web of Science ®Google Scholar
• Tachkov K, Mitkova Z, Boyadzieva V, et al. Did the introduction of biosimilars influence their prices and utilization? The case of biologic disease modifying antirheumatic drugs (bDMARD) in Bulgaria. Pharmaceuticals. 2021;14(1):64.
   Web of Science ®Google Scholar
• Tamer J, Grozev J, Kamusheva M, et al. PNS155 access of bulgarian patients to biosimilar medicines. Value Health. 2019;22(3):S787.
   Google Scholar
• Tubic B, Marković-Peković V, Jungić S, et al. Availability and accessibility of monoclonal antibodies in Bosnia and Herzegovina: findings and implications. Medicine Access @ Point of Care. 2021;5:239920262110276–239920262110277.
   Google Scholar
• Stoyanova S, Yordanov E, Hristov E, et al. Availability, affordability and drug utilization of biosimilar medicinal products, containing monoclonal antibodies in Bulgaria. SAGE J Generic Med. 2021.
   Google Scholar
• Povero M, Pradelli L. Funding innovation thanks to anti-TNF-α biosimilars uptake. Econom Imp Italy. 2020; 21(1).
   Google Scholar
• Inotai A, Csanádi M, Vitezic D, et al. Policy practices to maximise social benefit from biosimilars. J Bioequiv Availab. 2017;(9):467–472.
   Google Scholar
• Moorkens E, Vulto AG, Huys I, et al. Policies for biosimilar uptake in Europe: an overview. PLoS One. 2017;12(12):e0190147.
   PubMed Web of Science ®Google Scholar
• Moorkens E, Godman B, Huys I, et al. The expiry of humira® market exclusivity and the entry of adalimumab biosimilars in Europe: an overview of pricing and national policy Meas Front Pharmacol. 2020;11:591134.
   PubMed Web of Science ®Google Scholar
• Flynn J, Gerriets V. Pembrolizumab. 2021. StatPearls Publishing LLC. Bookshelf ID: NBK546616PMID: 31536223
   Google Scholar
• Kwok G, Yau TC, Chiu JW, et al. Pembrolizumab (keytruda). Hum Vaccin Immunother. 2016;12(11):2777–2789.
   PubMed Web of Science ®Google Scholar
• Elias F, Bou-Orm IR, Adib SM, et al. Cost of oncology drugs in the Middle-Eastern country of Lebanon: an update (2014-2016). J Glob Oncol. 2018;4:1–7.
   PubMed Web of Science ®Google Scholar
• Oncology pharma costs to exceed $150 billion by 2020. Manag Care. 2016;25(10):40.
   Google Scholar
• Investigation Report on China’s Pembrolizumab Market, 2021–2025. April 2021. Available online: https://www.researchandmarkets.com/reports/5312028/investigation-report-on-chinas-pembrolizumab?utm_source=GNOM&utm_medium=PressRelease&utm_code=d7f6c8&utm_campaign=1525398+-+China+Pembrolizumab+Market+Report+2021%3a+Market+-Size+will+Expand+in+the+Future+Due+to+the+Increased+Numbers+of+Approved+Indications&utm_exec=chdo54prd.
   Google Scholar
• Denis H, Davoine C, Bermudez E, et al. [Specific immunotherapies in the treatment of cancers]. Bull Cancer. 2019;106(1):37–47.
   PubMed Web of Science ®Google Scholar
• Bensimon AG, Zhou ZY, Jenkins M, et al. An economic evaluation of pembrolizumab versus other adjuvant treatment strategies for resected high-risk stage III melanoma in the USA. Clin Drug Investig. 2020;40(7):629–643.
   PubMed Web of Science ®Google Scholar
• Barrington DA, Dilley SE, Smith HJ, et al. Pembrolizumab in advanced recurrent endometrial cancer: a cost-effectiveness analysis. Gynecol Oncol. 2019;153(2):381–384.
   PubMed Web of Science ®Google Scholar
• Insinga RP, Vanness DJ, Feliciano JL, et al. Cost-effectiveness of pembrolizumab in combination with chemotherapy in the 1st line treatment of non-squamous NSCLC in the US. J Med Econ. 2018;21(12):1191–1205.
   PubMed Web of Science ®Google Scholar
• Bensimon AG, Zhong Y, Swami U, et al. Cost-effectiveness of pembrolizumab with axitinib as first-line treatment for advanced renal cell carcinoma. Curr Med Res Opin. 2020;36(9):1507–1517.
   PubMed Web of Science ®Google Scholar