References
- Silva APS, Coelho PV, Anazetti M, et al. Targeted therapies for the treatment of non-small-cell lung cancer: monoclonal antibodies and biological inhibitors. Hum Vaccin Immunother. 2017 Apr 03;13(4):843–853. doi: 10.1080/21645515.2016.1249551
- Behl A, Wani ZA, Das NN, et al. Monoclonal antibodies in breast cancer: a critical appraisal. Crit Rev Oncol Hematol. 2023 Mar 01;183:103915.
- Pérez-Herrero E, Fernández-Medarde A. Advanced targeted therapies in cancer: drug nanocarriers, the future of chemotherapy. Eur J Pharm Biopharm. 2015 Jun;93:52–79. doi: 10.1016/j.ejpb.2015.03.018
- Ciavarella S, Milano A, Dammacco F, et al. Targeted therapies in cancer. BioDrugs. 2010 Apr 01;24(2):77–88. doi: 10.2165/11530830-000000000-00000
- U.S. Food and Drug Administration. FDA and FTC collaborate to advance competition in the biologic marketplace, [2023 Aug 11]. Available from: https://www.fda.gov/news-events/fda-voices/fda-and-ftc-collaborate-advance-competition-biologic-marketplace
- U.S. Food and Drug Administration. Biosimilars. cited 2022 Aug 11]. Available from: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
- Association for Accessible Medicines. The U.S. Generic & biosimilar medicines savings report 2022 [cited 2023 Aug 11]. Available from://efaidnbmnnnibpcajpcglclefindmkaj/https://accessiblemeds.org/sites/default/files/2022-09/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf
- American Medical Association. Report: 2022 U.S. Generic and Biosimilar Medicines Savings Report 2022 [cited 2023 Aug 11].
- Thill M, Thatcher N, Hanes V, et al. Biosimilars: what the oncologist should know. Future Oncol. 2019 Apr;15:(10):1147–1165.
- Martin K, Bégaud B, Latry P, et al. Differences between clinical trials and postmarketing use. Br J Clin Pharmacol. 2004 Jan;57:(1):86–92.
- U.S. Food and Drug Administration. Biosimilar product information [2023 Aug 11]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
- 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 Sep;27:(6):1432–1438.
- Pivot X, Pegram M, Cortes J, et al. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019 Oct;120:1–9. doi: 10.1016/j.ejca.2019.07.015
- Rhodes W, DeClue RW, Accortt NA, et al. Real-world use of bevacizumab-awwb, a bevacizumab biosimilar, in US patients with metastatic colorectal cancer. Future Oncol. 2021 Dec;17:(36):5119–5127.
- Xue X, Truong B, Qian J. Adverse event reporting of marketed biosimilar and biological monoclonal antibody cancer treatments in the United States. Expert Opin Biol Ther. 2023 Mar;9:1–9.
- US Food and Drug Administration. Questions and answers on FDA’s adverse event reporting system (FAERS). 2018 [cited 2023 Aug 11]. Available from: https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers
- U.S. Food and Drug Administration. Purple book: lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations 2020 [cited 2023 Aug 16]. Available from: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or
- U.S. Food and Drug Administration. Biosimilar product information 2022 [cited 2023 Aug 16]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
- U.S. Food and Drug Administration. Nonproprietary naming of biological products guidance for industry. 2019 [cited 2023 Aug 16]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/nonproprietary-naming-biological-products-guidance-industry
- U.S. Food and Drug Administration. What is a serious adverse event?, 2016 [cited 2023 Aug 16]. Available from: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
- BioPortal. Medical dictionary for regulatory activities terminology (MedDRA) 2023 [cited 2023 Aug 16]. Available from: https://bioportal.bioontology.org/ontologies/MEDDRA
- Ji X, Cui G, Xu C, et al. Combining a pharmacological network model with a bayesian signal detection algorithm to improve the detection of adverse drug events. Front Pharmacol. 2021;12:773135. doi: 10.3389/fphar.2021.773135
- Trillenberg P, Sprenger A, Machner B. Sensitivity and specificity in signal detection with the reporting odds ratio and the information component. Pharmacoepidemiol Drug Saf. 2023 Aug;32(8):910–917. doi: 10.1002/pds.5624
- Rahman MM, Alatawi Y, Cheng N, et al. Methodological considerations for comparison of brand versus generic versus authorized generic adverse event reports in the US food and drug administration adverse event reporting system (FAERS). Clin Drug Investig. 2017 Dec;37:(12):1143–1152.
- Levine JG, Tonning JM, Szarfman A. Reply: the evaluation of data mining methods for the simultaneous and systematic detection of safety signals in large databases: lessons to be learned. Br J Clin Pharmacol. 2006 Jan;61(1):105–113. author reply 115-7. doi: 10.1111/j.1365-2125.2005.02510.x
- Avouac J, Drumez E, Hachulla E, et al. COVID-19 outcomes in patients with inflammatory rheumatic and musculoskeletal diseases treated with rituximab: a cohort study. Lancet Rheumatol. 2021 Jun;3:(6):e419–e426.
- Caldito NG, Shirani A, Salter A, et al. Adverse event profile differences between rituximab and ocrelizumab: findings from the FDA adverse event reporting database. Mult Scler. 2021 Jun;27:(7):1066–1076.
- Paul F, Cartron G. Infusion-related reactions to rituximab: frequency, mechanisms and predictors. Expert Rev Clin Immunol. 2019 Apr 03;15(4):383–389.
- Triesel K, Seabury R, Miller C, et al. Rituximab-pvvr is not an independent predictor for infusion reactions in a cohort given rituximab-pvvr or rituximab: a single-center retrospective study. J Oncol Pharm Pract. 2022 Jun 01;28(4):1024–1025. doi: 10.1177/10781552221086222
- Thatcher N, Goldschmidt JH, Thomas M, et al. Efficacy and safety of the biosimilar ABP 215 compared with Bevacizumab in patients with advanced nonsquamous non-small cell lung cancer (MAPLE): a randomized, double-blind, phase III study. Clin Cancer Res. 2019 Apr 1;25(7):2088–2095. doi: 10.1158/1078-0432.CCR-18-2702
- Man Y, Yu H, Mukherjee S, et al. Incidence of hypertension and proteinuria in patients treated with bevacizumab versus bevacizumab biosimilar. J Clin Oncol. 2021;39(3_suppl):83–83. doi: 10.1200/JCO.2021.39.3_suppl.83
- Fehr M, Catschegn S, Madon J, et al. The influence of bevacizumab on platelet function. Swiss Med Wkly. 2011;141(2930):w13243–w13243. doi: 10.4414/smw.2011.13243
- A post-marketing surveillance to assess the safety and effectiveness of Zirabev in domestic patients with various cancer. 2022 [cited 2023 Aug 16]. Available from: https://clinicaltrials.gov/study/NCT04889495?intr=Zirabev&rank=1
- Trastuzumab‐Induced maculopapular rash: fact or fiction? 2014 [2023 Aug 11]. Available from: https://shmabstracts.org/abstract/trastuzumabinduced-maculopapular-rash-fact-or-fiction/
- Food and Drug Administration. Highlights of prescribing information. 2019 [cited 2023 Aug 16]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf
- Oza B, Radhakrishna S, Pipalava P, et al. Pharmacovigilance of biosimilars - why is it different from generics and innovator biologics? J Postgrad Med. 2019 Oct;65:(4):227–232.
- McKinnon RA, Cook M, Liauw W, et al. Biosimilarity and interchangeability: principles and evidence: a systematic review. BioDrugs. 2018 Feb;32:(1):27–52.
- U.S. FOOD & DRUG ADMINISTRATION. Review and approval. Available from: https://www.fda.gov/drugs/biosimilars/review-and-approval