References
- Pierpont TM, Limper CB, Richards KL. Past, present, and future of rituximab—the world’s first oncology monoclonal antibody therapy. Front Oncol. 2018;8:163.
- US Food and Drug Administration. Rituxan: BLA approval letter. 1997. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ritugen112697L.htm [accessed 29 November 2022].
- US Food and Drug Administration. Rituxan: highlights of prescribing information. 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5467lbl.pdf [accessed 29 November 2022].
- European Medicines Agency. MabThera: scientific discussion. 2006. Available at: https://www.ema.europa.eu/en/documents/scientific-discussion/mabthera-epar-scientific-discussion_en.pdf [accessed 29 November 2022].
- European Medicines Agency. MabThera: summary of product characteristics. 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/mabthera-epar-product-information_en.pdf [cited 29 November 2022].
- Dreyling M, Ghielmini M, Rule S, et al. Newly diagnosed and relapsed follicular lymphoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32:298–308.
- Tilly H, Gomes da Silva M, Vitolo U, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(5):v116–v125.
- Ministry of Food and Drug Safety. Biological products. 2016. Available at: https://www.mfds.go.kr/eng/brd/m_30/view.do?seq=69797 [cited 29 November 2022].
- US Food and Drug Administration. Truxima (CT-P10): highlights of prescribing information. 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761088s018lbl.pdf [cited 29 November 2022].
- European Medicines Agency. Truxima: summary of product characteristics. 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/truxima-epar-product-information_en.pdf [cited 29 November 2022].
- Bloomberg. ‘First mover to game changer’: Celltrion announces 2020-2030 strategy at the 38th J.P. Morgan Healthcare Conference. 2020. Available at: https://www.bloomberg.com/press-releases/2020-01-16/-first-mover-to-game-changer-celltrion-announces-2020-2030-strategy-at-the-38th-j-p-morgan-healthcare-conference [cited 29 November 2022].
- Diaz LP, Millan S, Chaban N, et al. Current state and comparison of the clinical development of bevacizumab, rituximab and trastuzumab biosimilars. Future Oncol. 2021;17(19):2529–2544.
- Lee KH, Lee J, Bae JS, et al. Analytical similarity assessment of rituximab biosimilar CT-P10 to reference medicinal product. mAbs. 2018;10(3):380–396.
- Park W, Bozic-Majstorovic L, Milakovic D, et al. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. mAbs. 2018;10(6):934–943.
- Yoo DH, Suh C-H, Shim SC, et al. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017;76(3):566–570.
- Ogura M, Sancho JM, Cho S-G, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematol. 2018;5(11):e543–e53.
- Kim WS, Buske C, Ogura M, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. Lancet Haematol. 2017;4:e362–e373.
- Buske C, Jurczak W, Sancho JM, et al. Long-term efficacy and safety of CT-P10 or rituximab in untreated advanced follicular lymphoma: a randomized phase 3 study. Blood Adv. 2021;5:3354–3361.
- Suh CH, Yoo DH, Berrocal Kasay A, et al. Long-term efficacy and safety of biosimilar CT-P10 versus innovator rituximab in rheumatoid arthritis: 48-week results from a randomized phase III trial. BioDrugs. 2019;33:79–91.
- Shim SC, Bozic-Majstorovic L, Berrocal Kasay A, et al. Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial. Rheumatology (Oxford). 2019;58:2193–2202.
- Song NK, Musa H, Soriano M, et al. Safety and efficacy comparisons of rituximab biosimilars to the reference product in patients with cancer: a systematic meta-analysis review. J Pharm Pract Res. 2022;52:331–355.
- Gulacsi L, Brodszky V, Baji P, et al. The rituximab biosimilar CT-P10 in rheumatology and cancer: a budget impact analysis in 28 European countries. Adv Ther. 2017;34:1128–1144.
- Almaaytah A. Budget impact analysis of switching to rituximab’s biosimilar in rheumatology and cancer in 13 countries within the Middle East and North Africa. Clinicoecon Outcomes Res. 2020;12:527–534.
- Holm JEJ, Ruppert JG, Ramsden SD. Impact of changing regulations and the dynamic nature of European risk management plans for human medicines on the lifecycle of safety concerns. Pharmaceut Med. 2022;36:33–46.
- Ball G, Reblin T, Buchanan J, et al. A framework for safety evaluation throughout the product development life-cycle. Ther Innov Regul Sci. 2020;54:821–830.
- Lin LA, Zhang Y, Straus W, et al. Integrative analysis of randomized clinical trial and observational study data to inform post-marketing safety decision-making. Ther Innov Regul Sci. 2022;56:423–432.
- Zinzani PL, Dreyling M, Gradishar W, et al. Are biosimilars the future of oncology and haematology? Drugs. 2019;79:1609–1624.
- 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.
- European Medicines Agency. Truxima (rituxumab): public assessment report. 2016. Available at: https://www.ema.europa.eu/en/documents/assessment-report/truxima-epar-public-assessment-report_en.pdf [cited 29 November 2022].
- US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015. Available at: https://www.fda.gov/media/82647/download [cited 29 November 2022].
- European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf [cited 29 November 2022].
- Ministry of Food and Drug Safety. 2015. Truxima (rituximab): prescribing information [Korean]. Available at: https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=201504895 [cited 29 November 2022].
- Stone JH, Hoffman GS, Merkel PA, et al. A disease-specific activity index for Wegener’s granulomatosis: modification of the Birmingham Vasculitis Activity Score. International Network for the Study of the Systemic Vasculitides (INSSYS). Arthritis Rheum. 2001;44:912–920.
- Mendes D, Abrantes J, Rigueiro G, et al. Real-world intensive safety monitoring of biosimilars rituximab and trastuzumab in a Portuguese oncology hospital. J Oncol Pharm Pract. 2021;27:1432–1438.
- Yun H, Xie F, Delzell E, et al. Risks of herpes zoster in patients with rheumatoid arthritis according to biologic disease-modifying therapy. Arthritis Care Res (Hoboken). 2015;67:731–736.
- Curtis JR, Xie F, Yun H, et al. Real-world comparative risks of herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis. Ann Rheum Dis. 2016;75:1843–1847.
- Liao TL, Chen YM, Liu HJ, et al. Risk and severity of herpes zoster in patients with rheumatoid arthritis receiving different immunosuppressive medications: a case-control study in Asia. BMJ Open. 2017;7:e014032.
- Liao T-L, Lin C-H, Chen -H-H, et al. Significant associations of neurological complications of herpes zoster with stroke in rheumatoid arthritis patients. J Am Heart Assoc. 2017;6:e006304.
- Rutherford AI, Patarata E, Subesinghe S, et al. Opportunistic infections in rheumatoid arthritis patients exposed to biologic therapy: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis. Rheumatology (Oxford). 2018;57:997–1001.
- Lunardon L, Tsai KJ, Propert KJ, et al. Adjuvant rituximab therapy of pemphigus: a single-center experience with 31 patients. Arch Dermatol. 2012;148:1031–1036.
- Kwak LW, Sancho JM, Cho SG, et al. Efficacy and safety of CT-P10 versus rituximab in untreated low-tumor-burden follicular lymphoma: final results of a randomized phase III study. Clin Lymphoma Myeloma Leuk. 2022;22:89–97.
- Lee K, Ha JY, Jung AR, et al. The clinical outcomes of rituximab biosimilar CT-P10 (Truxima®) with CHOP as first-line treatment for patients with diffuse large B-cell lymphoma: real-world experience. Leuk Lymphoma. 2020;61:1575–1583.
- McBride A, Daniel S, Driessen MT, et al. Assessment of rituximab-abbs, a biosimilar, and rituximab outcomes in patients with CLL or NHL: a real-world UK study. Leuk Res. 2021;111:106671.
- Coiffier B, Haioun C, Ketterer N, et al. Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study. Blood. 1998;92:1927–1932.
- Walewski J, Paszkiewicz-Kozik E, Michalski W, et al. First-line R-CVP versus R-CHOP induction immunochemotherapy for indolent lymphoma with rituximab maintenance. A multicentre, phase III randomized study by the Polish Lymphoma Research Group PLRG4. Br J Haematol. 2020;188:898–906.
- Ghielmini M, Schmitz SF, Cogliatti S, et al. Effect of single-agent rituximab given at the standard schedule or as prolonged treatment in patients with mantle cell lymphoma: a study of the Swiss Group for Clinical Cancer Research (SAKK). J Clin Oncol. 2005;23:705–711.
- Haematological Malignancy Research Network. QuickStats. 2022. Available at: https://hmrn.org/statistics/quickstats [cited 29 November 2022].
- Chatzidionysiou K, Lie E, Lukina G, et al. Rituximab retreatment in rheumatoid arthritis in a real-life cohort: data from the CERERRA collaboration. J Rheumatol. 2017;44:162–169.
- Vander Cruyssen B, Durez P, Westhovens R, et al. The Belgian MIRA (MabThera In Rheumatoid Arthritis) registry: clues for the optimization of rituximab treatment strategies. Arthritis Res Ther. 2010;12:R169.
- Melville AR, Md Yusof MY, Fitton J, et al. Real-world experience of effectiveness of non-medical switch from originator to biosimilar rituximab in rheumatoid arthritis. Rheumatology (Oxford). 2021;60:3679–3688.