Biosimilars: A Brief Overview
Year 2026,
Volume: 30 Issue: 1, 134 - 144, 11.01.2026
Dhanashree Sanap
,
Anil Dindigala
Abstract
In a world of high competition, expensive health care costs and the need for patient access to various biologic treatments lead to the development of biosimilars. Biosimilar is a biological product that has great similarity to a biologic drug which was taken as a reference having no clinical differences. Companies are eligible to manufacture them when the exclusive patent on the biological product has expired. They are approved according to the same standards of pharmaceutical quality. As they are comparatively cheaper than biological products, they have better reach among many patients. They are mainly targeted towards treating non-communicable diseases such as cancer, asthma, and arthritis. An alarming rise of cases of non-communicable diseases is being seen across various developing countries thereby increasing the value of biosimilars. Versavo is a classic example of a biosimilar product launched in India which is referenced from Roche’s Avastin which has shown its effectiveness in the treatment of various types of cancers. Even though biosimilars accomplish the same results as branded drugs, they have a different composition and their development period is longer than the generic drugs.
References
-
[1] Lu B, Dvorani E, Nguyen L, Beca JM, Mercer RE, Andrea Adamic BA, Caroline M, Chan KKW. Cost-effectiveness analysis of bevacizumab biosimilars versus originator bevacizumab for metastatic colorectal cancer: a comparative study using real-world data. Value in Health. 2024; 27(12): 1689-1697. https://doi.org/10.1016/j.jval.2024.07.018.
-
[2] Trapani D, Curigliano G. The global landscape of drug development of trastuzumab biosimilars. J Cancer Policy. 2021; 28: 100273. https://doi.org/10.1016/j.jcpo.2021.100273.
-
[3] Li EC, Abbas R, Jacobs IA, Yin D. Considerations in the early development of biosimilar products. Drug Discov Today. 2015; 20 Suppl 2: 1-9. https://doi.org/10.1016/j.drudis.2014.12.017.
-
[4] Bui LA, Hurst S, Finch GL, Ingram B, Jacobs IA, Kirchhoff CF, Ng CK, Ryan AM. Key considerations in the preclinical development of biosimilars. Drug Discov Today. 2015; 20 Suppl 1: 3-15. https://doi.org/10.1016/j.drudis.2015.03.011.
-
[5] Trapani D, Curigliano G. The global landscape of drug development of trastuzumab biosimilars. J Cancer Policy. 2021; 28: 100273. https://doi.org/10.1016/j.jcpo.2021.100273.
-
[6] Broer LN, Knapen DG, Groot DJA, Mol PGM, Kosterink JGW, Vries EGE. Monoclonal antibody biosimilars for cancer treatment. iScience.2024; 27(6): 110115. https://doi.org/10.1016/j.isci.2024.110115.
-
[7] Douez E, D’Atri V, Guillarme D, Antier D, Guerriaud M, Beck A, Watier H, Foucault-Fruchard L. Why is there no biosimilar of Erbitux®? J Pharm Biomed Anal. 2023; 234:115544. https://doi.org/10.1016/j.jpba.2023.115544.
-
[8] AL-Sabbagh A, Olech E, McClellan JE, Kirchhoff CF. Development of biosimilars. Semin Arthritis Rheum. 2016; 45(5 Suppl): S11-S18. https://doi.org/10.1016/j.semarthrit.2016.01.002.
-
[9] Lee CWC, Kesselheim AS, Sarpatwari A. Clinical Development Times for Biosimilars in the United States. Mayo Clin Proc. 2020; 95(10): 2152-2154. https://doi.org/10.1016/j.mayocp.2020.06.039.
-
[10] Urbányi Z. Quality similarity-driven development of biosimilar monoclonal antibodies. Drug Discov Today Technol. 2020; 38: 1-8. https://doi.org/10.1016/j.ddtec.2021.06.001.
-
[11] Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015; 44(6): S2-S8. https://doi.org/10.1016/j.semarthrit.2015.04.002.
-
[12] Daniel Barmas-Alamdari D, Cortes B, Rai R, Lieberman R. Biosimilars in the Retina. Adv Ophthalmol Optom. 2024; 9(1): 175-185. https://doi.org/10.1016/j.yaoo.2024.02.013.
-
[13] Masuda K, Watanabe K, Ueno T, Nakazawa Y, Tanabe Y, Ushiki-Kaku Y, Ogawa-Goto K, Ehara Y, Saeki H, Okumura T, Nonaka K. Novel cell line development strategy for monoclonal antibody manufacturing using translational enhancing technology. J Biosci Bioeng. 2022; 133(3): 273-280. https://doi.org/10.1016/j.jbiosc.2021.11.010
-
[14] Yang J, Liu R, Granghaud A, Zaidi O, Stephens J. Biosimilar pegfilgrastim may offer affordable treatment options for patients in France: a budget impact analysis on the basis of clinical trial and real-world data. J Med Econ. 2021; 24(1): 665-674. https://doi.org/10.1080/13696998.2021.1922252.
-
[15] Gupta T, Seshadri S. Charge variants of proposed biosimilar to Omalizumab: Isolation, purification and analysis by HPLC methods. Ann Pharm Fr. 2024; 82(1):64-71. https://doi.org/10.1016/j.pharma.2023.09.003.
-
[16] Vergara I, Herrera-Noreña JS, López-Pacheco C, Soldevila G, Ortega E. Flow cytometry: A powerful analytical technique for characterizing the biological function of biotherapeutics and biosimilars. J Pharm Biomed Anal. 2023; 235: 115680. https://doi.org/10.1016/j.jpba.2023.115680.
-
[17] Ratih R, Asmari M, Abdel-Megied AM, Elbarbry F, Deeb SE. Biosimilars: Review of regulatory, manufacturing, analytical aspects and beyond. Microchem J. 2021; 165(5): 106143. http://dx.doi.org/10.1016/j.microc.2021.106143.
-
[18] Cageling R, Carillo S, Boumeester AJ, Lubbers-Geuijen K, Bones J, Joo K. Microfluidic capillary electrophoresis - mass spectrometry for rapid charge-variant and glycoform assessment of monoclonal antibody biosimilar candidates. J Pharm Biomed Anal. 2024; 248: 116301. https://doi.org/10.1016/j.jpba.2024.116301.
-
[19] Castel J, DelauxS, Hernandez-Alba O, Cianférani S. Recent advances in structural mass spectrometry methods in the context of biosimilarity assessment: from sequence heterogeneities to higher order structures. J Pharm Biomed Anal. 2023; 236: 115696. https://doi.org/10.1016/j.jpba.2023.115696.
-
[20] Vergara I, Herrera-Noreña JS, López-Pacheco C, Soldevila G, Ortega E. Flow cytometry: A powerful analytical technique for characterizing the biological function of biotherapeutics and biosimilars. J Pharm Biomed Anal. 2023; 235: 115680. https://doi.org/10.1016/j.jpba.2023.115680.
-
[21] Urbano A, Plaza J, Picado C, Mora FD. Combined analytical assays for the characterization of drugs binding to human IgE: Applicability to omalizumab-bearing biosimilar candidates assessment. Biomed Pharmacother 2023; 169: 115848. https://doi.org/10.1016/j.biopha.2023.115848.
-
[22] Duivelshof BL, Jiskoot W, Beck A, Veuthey JL, Guillarme D, D’Atri V. Glycosylation of biosimilars: Recent advances in analytical characterization and clinical implications. Anal Chim Acta. 2019; 1089: 1-18. https://doi.org/10.1016/j.aca.2019.08.044.
-
[23] Beck A, Diemer H, Ayoub D, Debaene F, Wagner-Rousset E, Carapito C, Dorsselaer AV, Sanglier-Cianférani S. Analytical characterization of biosimilar antibodies and Fc-fusion proteins. Trends Anal Chem. 2013; 48: 81-95. http://dx.doi.org/10.1016/j.trac.2013.02.014.
-
[24] Zhang W, Pan Z, Yuan Y. Elastic meta-analytic-predictive prior for dynamically borrowing information from historical data with application to biosimilar clinical trials. Contemp Clin Trials. 2021; 110: 106559. https://doi.org/10.1016/j.cct.2021.106559.
-
[25] Bhattacharya S, Rathore AS. A novel filter-assisted protein precipitation (FAPP) based sample pre-treatment method for LC-MS peptide mapping for biosimilar characterization. J Pharm Biomed Anal. 2023; 234: 115527. https://doi.org/10.1016/j.jpba.2023.115527.
-
[26] Tank P, Vora S, D'Souza F. Qualification of a LC-HRMS platform method for biosimilar development using NISTmab as a model. Anal Biochem. 2024; 688: 115475. https://doi.org/10.1016/j.ab.2024.115475.
-
[27] Wei K, Kou Y, Kan H, He W, Li J, Guo X. Biosimilars: navigating the regulatory maze across two worlds. Trends Biotechnol. 2023; 41(7): 847-850. https://doi.org/10.1016/j.tibtech.2023.02.007.
-
[28] Benahzil MA, Hadjaz IM, Mansouri K. The regulatory landscape of biosimilars: Algeria's efforts and progress made from 2006 to 2021Le cadre réglementaire des biosimilaires: efforts de l’Algérie et progrès réalisés de 2006 à 2021. Ann Pharm Fr. 2022; 80(4): 440-447. https://doi.org/10.1016/j.pharma.2021.11.002.
-
[29] Gascón P, Harbeck N, Rapoport BL, Anderson R, Brueckmann I, Howe S. Filgrastim biosimilar (EP2006): A review of 15 years’ post-approval evidence. Crit Rev Oncol Hematol. 2024; 196: 104306. https://doi.org/10.1016/j.critrevonc.2024.104306.
-
[30] Kudrin A, Knezevic I, Joung J, Kang H. Case studies on clinical evaluation of biosimilar monoclonal antibody: Scientific considerations for regulatory approval. Biologicals. 2015; 43(1): 1-10. https://doi.org/10.1016/j.biologicals.2014.11.002
-
[31] Pipalava P, Patel R, Mehta M, Dahiya M, Singh I, Jos V. An update on the animal studies conducted for biosimilar approvals – Regulatory requirement vs actual scenario. Regul Toxicol Pharmacol. 2019; 107: 104415. https://doi.org/10.1016/j.yrtph.2019.104415.
-
[32] Car ES, Barbier L, Vulto A, Huys I, Simoens S. HPR59 evolving global regulatory landscape for approval of biosimilars: a structured literature review on current challenges and future considerations. Value in Health. 2023; 26(12): S263-S264. http://dx.doi.org/10.1016/j.jval.2023.09.1377.
-
[33] Iqbal Z, Sadaf S. Scientific considerations in the regulatory approval of generic (or biosimilar) version of enoxaparin sodium – A lifesaving carbohydrate polymer. Regul Toxicol Pharmacol. 2023; 143: 105446. https://doi.org/10.1016/j.yrtph.2023.105446.
-
[34] Machado FLDS, Cañás M, Doubova SV, Urtasun MA, Marín GH, Osorio-de-Castro CGS, Albuquerque FC, Ribeiro TB, Pont L, Crisóstomo Landeros J, Roldán Saelzer J, Sepúlveda Viveros D, Acosta A, Machado Beltrán MA, Gordillo Alas LI, Orellana Tablas LA, Benko R, Convertino I, Bonaso M, Tuccori M, Kirchmayer U, Contreras Sánchez SE, Rodríguez-Tanta LY, Gutierrez Aures Y, Lin B, Alipour-Haris G, Eworuke E, Lopes LC. Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison. Regul Toxicol Pharmacol. 2023;144:105485. https://doi.org/10.1016/j.yrtph.2023.105485
-
[35] HS, Buckley A. 1566P - epoetin zeta for treatment of chemotherapy-induced and cancer-related anaemia: four-year post-marketing surveillance. Ann Oncol. 2012; 23(9): ix505. https://doi.org/10.1016/S0923-7534(20)34111-9.
-
[36] Blandizzi C, Galeazzi M, Valesini G. Transitioning from first- to second-generation biosimilars: an appraisal of regulatory and post-marketing challenges. Pharmacol Res. 2018; 128: 306-314. https://doi.org/10.1016/j.phrs.2017.10.015.
-
[37] Gascón P, Harbeck N, Rapoport BL, Anderson R, Brueckmann I, Howe S. Filgrastim biosimilar (EP2006): A review of 15 years’ post-approval evidence. Crit Rev Oncol Hematol. 2024; 196: 104306. https://doi.org/10.1016/j.critrevonc.2024.104306.
-
[38] Milone G, Penna M, Fernández F, Spitzer E, Millan S, Caso PD. Post-Marketing Surveillance with a Biosimilar of Rituximab (Novex®) in Argentina. Blood. 2017; 130(1): 2131. https://doi.org/10.1182/blood.V130.Suppl_1.2131.2131.
-
[39] Silva AM, Honda E, Watanabe T, Borsoi A. Rituximab biosimilar rtxm83 post-marketing surveillance in brazil: evaluation of the adverse events spontaneously reported to pharmacovigilance. Hematol Transfus Cell Ther. 2021; 43(1): S102. https://doi.org/10.1016/j.htct.2021.10.173.
-
[40] Tamura K, Hashimoto K, Nishikawa K. Clinical safety and efficacy of “filgrastim biosimilar 2” in Japanese patients in a post-marketing surveillance study. J Infect Chemother. 2018; 24(5): 363-369. https://doi.org/10.1016/j.jiac.2017.12.011.
-
[41] Cho SG, Jo JC, Jeon Y, Kim D, Yang DH, Lee WS. Safety and Effectiveness of Rituximab Biosimilar CT-P10 during Routine Clinical Practice: Final Analysis of a Post-Marketing Surveillance Study in the Republic of Korea. Expert Opin Biol Ther. 2022; 140(Suppl 1): 10960-10962. http://dx.doi.org/10.1182/blood-2022-156478.
-
[42] Bhargava T, Sahu S, Singh TK, Shrivastava D, Kumar A, Mohammad D, Srivastava A. Comparison of palonosetron and ondansetron in preventing postoperative nausea and vomiting in renal transplantation recipients: a randomized clinical trial. Braz J Anesthesiol. 2024; 74(1): 744251. https://doi.org/10.1016/j.bjane.2021.07.027.
-
[43] Rosillo-Meneses LA, Carrillo-Torres O, Gonzalez-Navarro P, Garcia-Garcia JA. Comparison of the antiemetic efficacy of propofol versus ondansetron in nasal surgery. Randomised clinical trial. Revista Médica del Hospital General de México. 2018; 81(2): 72-78. https://doi.org/10.1016/j.hgmx.2016.09.009
-
[44] Priyarega S, Natarajan R. An overview of biosimilars for cancer, diabetes mellitus, rheumatoid arthritis and other immune-mediated diseases approved between 2016 and 2021. Results Chem. 2022; 4: 100356. https://doi.org/10.1016/j.rechem.2022.100356.
-
[45] Cobb P, Niederwieser D, Cohen S, Hamm C, Burmester G, Seo N, Lehto SG, Hanes V. A review of the totality of evidence in the development of ABP 798, a rituximab biosimilar. Immunotherapy. 2022;14(9):727-740. https://doi.org/10.2217/imt-2022-0024.
-
[46] Yang J, Liu R, Granghaud A, Zaidi O, Stephens J. Biosimilar pegfilgrastim may offer affordable treatment options for patients in France: a budget impact analysis on the basis of clinical trial and real-world data. J Med Econ. 2021; 24(1): 665-674. https://doi.org/10.1080/13696998.2021.1922252.
-
[47] Agarwala SS, Nagl U, Guo X, Bellon A, Heyn J, Dimova-Dobreva M, Shen YM, Schaffar G, Humphrey M, Mathieson N, Koptelova N. A review of the totality of evidence supporting the development and approval of a pegfilgrastim biosimilar (LA-EP2006). Curr Med Res Opin. 2022; 38(6): 999-1009. https://doi.org/10.1080/03007995.2022.2061707.
-
[48] Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A randomized, double-blind, efficacy and safety study of PF-05280586 (a rituximab biosimilar) compared with rituximab reference product (MabThera®) in subjects with previously untreated CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL). BioDrugs. 2020; 34(2): 171-181. https://doi.org/10.1007/s40259-019-00398-7.
-
[49] Gürel B, Çapkın E, Parlar A, Özkan A, Çorbacıoğlu M, Dağlikoca DE, Yüce M. Optimized methods for analytical and functional comparison of biosimilar mAb drugs: A case study for Avastin, Mvasi, and Zirabev. Sci Pharm. 2022; 90(2): 36. https://doi.org/10.3390/scipharm90020036.
-
[50] D'Arpino A, Savoia M, Cirillo L, Despiégel N, Haffemayer B, Giannopoulou A, Gaikwad I. Pcn72 comparative cost analysis of subcutaneous trastuzumab originator (Herceptin®) vs intravenous trastuzumab biosimilar (Kanjinti) from a hospital perspective in Italy. Value in Health. 2019; 22(Suppl S3): S449. https://doi.org/10.1016/j.jval.2019.09.269.
-
[51] Li RK, Lipatov O, Adamchuk H, Vladimirov V, Yanez E, Banchero P, Freyman A, Hilton F, Thiele A, Vana A. Abstract P1-18-08: Trazimera (a trastuzumab biosimilar) in HER2-positive metastatic breast cancer: Long-term safety and overall survival data. Cancer Res. 2020; 80(Suppl 4): P1-18. http://dx.doi.org/10.1158/1538-7445.SABCS19-P1-18-08
-
[52] Perez T, Rico A, Boutière C, Maarouf A, Roudot M, Honoré S, Pelletier J, Bertault-Peres P, Audoin B. Comparison of rituximab originator (MabThera®) to biosimilar (Truxima®) in patients with multiple sclerosis. Mult Scler J. 2021; 27(4): 585-92. https://doi.org/10.1177/1352458520912170.
-
[53] Cornes P, Gascon P, Vulto AG and Aapro M. Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure. BioDrugs. 2020; 34(3): 255–263. https://doi.org/10.1007/s40259-020-00411-4
-
[54] Miller EM, Schwartzberg LS. Biosimilars for breast cancer: a review of HER2-targeted antibodies in the United States. Ther Adv Med Oncol. 2019; 11: 1758835919887044. https://doi.org/10.1177/1758835919887044.
-
[55] Abd-Rabou, Ahmed HH, Mohamed SH, Kotob S, Kishta MS. Nanotherapy: New approach for impeding hepatic cancer microenvironment via targeting multiple molecular pathways. Asian Pac J Cancer Prev. 2022; 23(12): 4261-4273. https://doi.org/10.31557/APJCP.2022.23.12.4261.
-
[56] Harbeck N, Gascón P, Krendyukov A, Hoebel N, Gattu S, Blackwell K. Safety profile of biosimilar filgrastim (Zarzio/Zarxio): a combined analysis of phase III studies. Oncologist. 2018; 23(4): 403-409. https://doi.org/10.1634/theoncologist.2017-0348.
-
[57] DeLaney K, Ippoliti S, Birdsall RE, Yu YQ. Peptide characterization and monitoring workflow for biosimilar mab drug products using a compliance ready lc-ms and informatics platform. Waters. 2023. Avaliable at; https://www.waters.com/content/dam/waters/en/library/posters/2023/2023asms_delaney_pepmap_printing.pdf?srsltid=AfmBOopgha82dPA6D22DHHvxx9JY95e3H5r2vlnMr8bsw_9MvQHbQ9h6.
-
[58] Reynolds KA, Pithadia DJ, Lee EB, Liao W, Wu JJ. Safety and effectiveness of anti-tumor necrosis factor-alpha biosimilar agents in the treatment of psoriasis. Am J Clin Dermatol. 2020; 21(4): 483-491. https://doi.org/10.1007/s40257-020-00507-1.
-
[59] Abitbol V, Benkhalifa S, Habauzit C, Marotte H. Navigating adalimumab biosimilars: an expert opinion. J Comp Eff Res. 2023; 12(11): e230117. https://doi.org/10.57264/cer-2023-0117.
-
[60] Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, Zhang M, Hackley S, Rehman MI, von Richter O, Alten R. Long-term efficacy, safety, and immunogenicity of the infliximab (IFX) biosimilar, PF-06438179/GP1111, in patients with rheumatoid arthritis after switching from reference IFX or continuing biosimilar therapy: week 54–78 data from a randomized, double-blind, phase III trial. BioDrugs. 2020; 34(2): 197-207. https://doi.org/10.1007/s40259-019-00403-z.
-
[61] Markus R, McBride HJ, Ramchandani M, Chow V, Liu J, Mytych D, Fanjiang G. A review of the totality of evidence supporting the development of the first adalimumab biosimilar ABP 501. Adv Ther. 2019; 36(8): 1833-1850. https://doi.org/10.1007/s12325-019-00979-6.
-
[62] Medicines A. Biosimilars: current approvals and pipeline agents. US Pharm. 2016; 41(10): 26-29.
-
[63] Schimmelpennink MC, Vorselaars AD, van Beek FT, Crommelin HA, Deneer VH, Keijsers RG, Veltkamp M. Efficacy and safety of infliximab biosimilar Inflectra® in severe sarcoidosis. Respir Med. 2018; 138: S7-13. https://doi.org/10.1016/j.rmed.2018.02.009.
-
[64] Heinemann L, Davies M, Home P, Forst T, Vilsbøll T, Schnell O. Understanding Biosimilar Insulins-Development, Manufacturing, and Clinical Trials. J Diabetes Sci Technol. 2023; 17(6): 1649-1661. https://doi.org/10.1177/19322968221105864.
-
[65] Gangwar N, Priyanka P, Rathore AS. Achieving charge variant profile of innovator molecule during development of monoclonal antibody based biosimilars – Use of media components. Biochem Eng J. 2022; 182: 108438. http://dx.doi.org/10.1016/j.bej.2022.108438.
-
[66] Shastri K, Clarke K, Ainslie-GarciaM, Ferko N. EE375 Cost Savings and the Opportunity for Expanded Treatment Access with Increased Use of Biosimilar Adalimumab in the United States. Value in Health. 2024; 27(6): S126. https://doi.org/10.1016/j.jval.2024.03.671.
-
[67] Paglinco S, Abdel-Rasoul M, McNicol M, Boyle B, Dotson J, Michel H, Maltz R. Infliximab market share and associated cost savings following biosimilar market entry. Gatroenterelogy. 2024; 166(3): S69. https://doi.org/10.3390/children12050656.
-
[68] Tak S, Methuku M. HPR192 Does Including Biosimilars Earlier in the Treatment Pathways Lead to Cost Savings in Rheumatology? Value in Health. 2023; 26(12): S287. https://doi.org/10.1016/j.jval.2023.09.1510.
-
[69] Kvien TK, Patel K, Strand V. The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems. Semin Arthritis Rheum. 2022; 52: 151939. https://doi.org/10.1016/j.semarthrit.2021.11.009.
-
[70] Alshehri N, Balkhi B. HSD74 Cost Savings as a Result of Biosimilar Medications Adoption in One of the Tertiary Governmental Hospitals in Riyadh, Saudi Arabia. Value in Health. 2023; 26(12): S308. http://dx.doi.org/10.1016/j.jval.2023.09.1625.
-
[71] Sun D, Andayani TM, Altyar A, MacDonald K, Abraham I. Potential Cost Savings From Chemotherapy-Induced Febrile Neutropenia With Biosimilar Filgrastim and Expanded Access to Targeted Antineoplastic Treatment Across the European Union G5 Countries: A Simulation Study. Clin Ther. 2015; 37(4): 842-857. https://doi.org/10.1016/j.clinthera.2015.01.011.
-
[72] Bhimji H, Eurich D, Mansell K, Mansell H. Potential and Realized Cost Savings with the Use of the Biosimilar Grastofil Vs Neupogen. Blood. 2019; 134(1): 2126. http://dx.doi.org/10.1182/blood-2019-122751.
-
[73] Ektare V, Bair A, Granghaud A, Liu R, Shane LG, Shelbaya A. Pbi6 economic model of cost savings with trastuzumab-qyyp (biosimilar trastuzumab) from the french buyer and payer perspectives. Value in Health. 2020; 23(1): S14-S15. https://doi.org/10.1016/j.jval.2020.04.075.
-
[74] Barat EC, Arrii MLE, Soubieux-Bourbon A, Daouphars M, Varin R, Tilleul PR. Cost effectiveness of using trastuzumab biosimilars compared to trastuzumab original drugs to treat breast cancer in a hospital setting. The Breast. 2023; 72: 103588. https://doi.org/10.1016/j.breast.2023.103588.
-
[75] Leung JH, Tai Y, Wang S, Fion HY, Tsung-Chin H, Chan AL. Cost-effectiveness of trastuzumab biosimilar combination therapy and drug wastage as first-line treatment for HER2-positive metastatic breast cancer. The Breast. 2022; 65: 91-97. https://doi.org/10.1016/j.breast.2022.07.007.
-
[76] Codreanu C, Popescu CC, Mogoșan C, Enache L, Daia S, Ionescu R, Opriș-Belinski D. Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis - A comparison in a real-world national cohort. Biologicals. 2019;62:27-32. https://doi.org/10.1016/j.biologicals.2019.10.009.
-
[77] Rezvani H, Mortazavizadeh SM, Allahyari A, Nekuee A, Najafi SN, Vahidfar M, Ghadyani M, Khosravi A, Qarib S, Sadeghi A, Esfandbod M, Rajaeinejad M, Rezvani A, Hajiqolami A, Payandeh M, Shazad B, Anjidani N, Meskinimood S, Alikhasi A, Karbalaeian M, Salari S. Efficacy and Safety of Proposed Bevacizumab Biosimilar BE1040V in Patients With Metastatic Colorectal Cancer: A Phase III, Randomized, Double-blind, Noninferiority Clinical Trial. Clin Ther. 2020;42(5):848-859. https://doi.org/10.1016/j.clinthera.2020.03.009.
-
[78] Holz FG, Oleksy PO, Ricci F, Kaiser PK, Kiefer J, Schmitz-Valckenberg S. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophtalmology. 2022; 129(1): 54-63. https://doi.org/10.1016/j.ophtha.2021.04.031.
-
[79] Della-Torre E, Lanzillotta M, Campochiaro C, Di-Colo G, Mancuso G, Dagna L. Efficacy and safety of rituximab biosimilar (CT-P10) in IgG4-related disease: an observational prospective open-label cohort study. Eur J Intern Med. 2021; 84: 63-67. https://doi.org/10.1016/j.ejim.2020.12.006.
-
[80] Mohan MVTK, Prajapati A, Kothari R, Mandal S, Rao Srikanth R, Nagarkar R, Khane S, Santa A, Dadke D. Efficacy and Safety of BP02 (Trastuzumab Biosimilar) in HER2-Positive Metastatic Breast Cancer: A Multicenter Phase III Study. Clin Drug Investig. 2024;44(7):513-525. https://doi.org/10.1016/j.annonc.2023.10.201.
-
[81] Hyung J, Lee JY, Kim JE, Yoon S, Yoo C, Hong YS, Jeong JH, Kim TW, Jeon S, Jun HR, Jung CK, Jang JP, Kim J, Chun SM, Ahn JH. Safety and efficacy of trastuzumab biosimilar plus irinotecan or gemcitabine in patients with previously treated HER2 (ERBB2)-positive non-breast/non-gastric solid tumors: a phase II basket trial with circulating tumor DNA analysis. ESMO Open. 2023;8(3):101583. https://doi.org/10.1016/j.esmoop.2023.101583.
-
[82] Mirjalili SZ, Sabourian R, Sadeghalvad M, Rezaei N. Therapeutic applications of biosimilar monoclonal antibodies: Systematic review of the efficacy, safety, and immunogenicity in autoimmune disorders. Int Immunopharmacol. 2021; 101(B): 108305. https://doi.org/10.1016/j.intimp.2021.108305.
-
[83] Chhapola-Shukla S. Efficacy and safety of omalizumab biosimilar in IGE mediated diseases and multimorbidities. Ann Allergy Asthma Immunol. 2023; 131(5-1): S76. https://doi.org/10.3389/fimmu.2024.1425906.
-
[84] Krishnan K, Raman S, Anand Moses CR, Rajesh RP, Gupta A, Mudaliar V, Vimal J. Phase 3 efficacy and safety trial of proposed liraglutide biosimilar for reduction of glycosylated hemoglobin (HbA1c) in patients with Type 2 diabetes mellitus. Diabetes Res Clin Pract. 2024;207:111034. https://doi.org/10.1016/j.diabres.2023.111034.
-
[85] Karkhaneh R, Faghihi H, Riazi-Esfahani H, Abrishami M, Bazvand F. Evaluating the Efficacy and Safety of Aflibercept Biosimilar (P041) Compared with Originator Product in Patients with Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2024; 8(8): 744-753. https://doi.org/10.1016/j.oret.2024.02.012.
-
[86] Bressler NM, Kaiser PK, Do DV, Nguyen QD, Park KH, Woo SJ, Sagong M, Bradvica M, Kim MY, Kim S, Sadda SR. Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review. Surv Ophthalmol. 2024; 69(4): 521-538. https://doi.org/10.1016/j.survophthal.2024.03.009.
-
[87] Kay J. Are there benefits and risks to biosimilars from a patient perspective? Rheum Dis Clin. 2019; 45(3): 465-476. https://doi.org/10.1016/j.rdc.2019.04.001.
-
[88] Tsuruta LR, Lopes dos Santos M, Moro AM. Biosimilars advancements: moving on to the future. Biotechnol Prog. 2015; 31(5): 1139-1149. https://doi.org/10.1002/btpr.2066.
-
[89] Sheridan M, Massich M, and Ashourian N. Biosimilars: From Production to Patient. J Infus Nurs. 2024; 47(1): 19–29. https://doi.org/10.1097/nan.0000000000000528.
-
[90] Mysler E, Azevedo VF, Danese S, Alvarez D, Iikuni N, Ingram B, Mueller M, Peyrin-Biroulet L. Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience? Drugs. 2021; 81(16): 1859–1879. https://doi.org/10.1007/s40265-021-01610-1.
-
[91] Scheinberg M, Pineda C, Castañeda-Hernández G, Zarbá JJ, Damião A, Arantes LH, Jacobs I. Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America. MAbs. 2018; 10(6): 827–842. https://doi.org/10.1080/19420862.2018.1484977.
-
[92] Bas TG and Duarte V. Biosimilars in the Era of Artificial Intelligence—International Regulations and the Use in Oncological Treatments. Pharmaceuticals (Basel). 2024; 17(7): 925. https://doi.org/10.3390/ph17070925.
-
[93] Oliveira BD, Lopes ACDF, and Soárez PCD. Health technology assessment of biosimilars worldwide: a scoping review. Health Res Policy Syst. 2020; 18(1): 95. https://doi.org/10.1186/s12961-020-00611-y.
-
[94] Agbogbo FK, Ecker DM, Farrand A, Han K, Khoury A, Martin A, McCool J, Rasche U, Rau TD, Schmidt D, Sha M, Treuheit N. Current perspectives on biosimilars. J Ind Microbiol Biotechnol. 2019; 46(9-10): 1297–1311. https://doi.org/10.1007/s10295-019-02216-z.
-
[95] Kang HN, Thorpe R, Knezevic I. The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019. Biol Sci. 2020; 65: 1–9. https://doi.org/10.1016/j.biologicals.2020.02.005.
-
[96] Daubenfeld T, Dassow J, Keßler M, Schulze J. Understanding the market dynamics of biosimilars. J Bus Chem. 2016; 13(1).
-
[97] Abdel-Maged AE, Mikhaeil MF, Elkordy AI, Gad Am, Elshazly MM. Biosimilars production in Africa opportunities and challenges. Regul Toxicol Pharmacol. 2024; 149: 105626. https://doi.org/10.1016/j.yrtph.2024.105626.
-
[98] Alten R and Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015; 44(6 Suppl): S2-S8. https://doi.org/10.1016/j.semarthrit.2015.04.002.
-
[99] Johnson AN, Fulgoni A, Almgren M. Quantifying challenges to development of generics and biosimilars in non-hodgkin's lymphoma therapeutics: the future of low-cost alternatives from monoclonal antibodies to CAR-T. Blood. 2023; 142 (1-2): 5148. https://doi.org/10.1182/blood-2023-187818.
-
[100] Jaffar-Aghaei M, Khanipour F, Maghsoudi A, Sarvestani R, Mohammadian M, Maleki M, Havasi F, Rahmani H, Karagah A, Kazemali M. QbD-guided pharmaceutical development of Pembrolizumab biosimilar candidate PSG-024 propelled to industry meeting primary requirements of comparability to Keytruda®. Eur J Pharm Sci. 2022; 173: 106171. https://doi.org/10.1016/j.ejps.2022.106171.
-
[101] Urbányi Z. Quality similarity-driven development of biosimilar monoclonal antibodies. Drug Discov Today Technol. 2020; 38: 1-8. https://doi.org/10.1016/j.ddtec.2021.06.001.