Are Biosimilars the Future of Oncology and Haematology?
- 125 Downloads
Biological drugs are vital but often high-cost components of cancer treatment. Several biosimilar versions of these drugs have been approved in Europe and/or the USA, with many more in development. However, there is some disconnect between the biosimilars that are approved for use and those accessible in clinical practice, with availability impacted by factors including patent litigation and complex healthcare insurance policies, particularly in the USA. Provided the barriers to widespread uptake can be overcome, biosimilars offer potential benefits including cost savings and improved patient access versus the reference product (RP). This article provides an up-to-date and focused perspective on the development and use of biosimilars in the haemato-oncology setting. European and US regulatory pathways governing biosimilar licensing demand that there are no clinically meaningful differences between a biosimilar and its RP. Pathways are rigorously enforced and involve comprehensive non-clinical evaluations and clinical trials in selected indications to establish the equivalence or non-inferiority of efficacy, and the comparability of safety, of the biosimilar versus its RP. ‘Indication extrapolation’ is only permitted if scientifically justifiable considering mechanism(s) of action, pharmacokinetics, immunogenicity and safety in relevant patient populations. Switching treatment from RP to biosimilar is supported by most available data, predominantly from indications other than cancer, and post-marketing pharmacovigilance programmes are warranted. Notably, the potential benefits of biosimilar cancer treatment may extend beyond direct cost savings: for example, the availability of biosimilars of common regimen components may help incentivise the evaluation and/or clinical use of new treatment approaches and novel drugs.
Medical writing support (including development of a draft outline and subsequent drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, fact checking and referencing) was provided by Emma Evans PhD, CMPP and Rick Flemming PhD, CMPP at Aspire Scientific Limited (Bollington, UK), and funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea). Drafts of the manuscript were reviewed by Dasom Choi at Celltrion Healthcare Co., Ltd.
Compliance with Ethical Standards
Medical writing support was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea). The final decision to submit was that of the authors.
Conflict of interest
PLZ has received honoraria from Janssen, Servier, Bristol-Myers Squibb, Merck, Celgene, Roche, Gilead; and has participated in advisory boards for Janssen, Servier, Bristol-Myers Squibb, Merck, Celgene, Roche, Gilead, Celltrion, Portola, Immune Design, TG Therapeutics. MD has received speaker honoraria from Bayer, Celgene, Gilead, Janssen, Roche; research support from Celgene, Janssen, Mundipharma, Roche (to institution); and has participated in advisory boards for Acerta, Bayer, Celgene, Gilead, Janssen, Mundipharma, Roche, Sandoz. WG has participated in independent data monitoring committees for Genentech and Seattle Genetics, and study steering committees for PUMA and AstraZeneca. MA has received research grants from Roche, Amgen, Johnson & Johnson, Novartis, Takeda Millénium, Chugai, Celgene, CAF-DCF Belgian Red Cross; travel grants from Roche, Bristol-Myers-Squibb, Amgen, Celgene; and has participated in advisory boards for Takeda, Bristol-Myers Squibb, Karyopharm, Gilead, Novartis. FJE has received research grants from Novartis, Pfizer, Genentech/Roche, Eli Lilly and Merrimack; has received consultancy fees from Celltrion Healthcare, Pfizer, Novartis, Genentech/Roche, Nanostring, AstraZeneca, Seattle Genetics and Celgene; and has received fees for participation in advisory boards for Celltrion Healthcare, Novartis and Genentech/Roche. SB was employed by Celltrion Healthcare Co. Ltd (Incheon, Republic of Korea) during preparation of this article, and is currently employed at the Shaare Zedek Medical Center, Israel. EGB has received consultancy fees from Janssen, Sandoz, Gilead; and speaker honoraria from F. Hoffmann-La Roche, Janssen, AbbVie. GC has received honoraria from Pfizer, Novartis, Lilly, Roche; fees for expert testimony and medical education from Pfizer; and has participated in advisory boards for Pfizer, Roche, Lilly, Novartis, Seattle Genetics, Celltrion.
Data sharing not applicable to this article as no datasets were generated or analysed during the current study.
This article does not contain any studies with human participants or animals performed by any of the authors.
- 2.Lee S-M, Jung J-H, Suh D, Jung Y-S, Yoo S-L, Kim D-W, et al. Budget impact of switching to biosimilar trastuzumab (CT-P6) for the treatment of breast cancer and gastric cancer in 28 European countries. BioDrugs. 2019;33(4):423–36. https://doi.org/10.1007/s40259-019-00359-0.CrossRefPubMedGoogle Scholar
- 3.European Medicines Agency. Inflectra: Summary of Medicinal Product Characteristics. 2019. https://www.ema.europa.eu/en/documents/product-information/inflectra-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 4.United States Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. 2015. https://www.fda.gov/media/82647/download. Accessed 02 Sep 2019.
- 5.British National Formulary. Rituximab medicinal forms. https://bnf.nice.org.uk/medicinal-forms/rituximab.html. Accessed 02 Sep 2019.
- 6.British National Formulary. Trastuzumab medicinal forms. https://bnf.nice.org.uk/medicinal-forms/trastuzumab.html. Accessed 02 Sep 2019.
- 7.Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. 2017. https://www.rand.org/pubs/perspectives/PE264.html. Accessed 02 Sep 2019.
- 9.QuintilesIMS. The impact of biosimilar competition in Europe. 2017. https://www.medicinesforeurope.com/wp-content/uploads/2017/05/IMS-Biosimilar-2017_V9.pdf. Accessed 02 Sep 2019.
- 11.National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology. Myeloid growth factors. Version 2.2018. https://www.nccn.org/professionals/physician_gls/pdf/myeloid_growth.pdf. Accessed 02 Sep 2019.
- 13.Grewal S, Ramsey S, Balu S, Carlson JJ. Cost-savings for biosimilars in the United States: a theoretical framework and budget impact case study application using filgrastim. Expert Rev Pharmacoecon Outcomes Res. 2018;18(4):447–54. https://doi.org/10.1080/14737167.2018.1476142.CrossRefPubMedGoogle Scholar
- 15.European Medicines Agency. Omnitrope. https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope. Accessed 02 Sep 2019.
- 16.United States Food and Drug Administration. Zarxio BLA approval letter. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125553Orig1s000ltr.pdf. Accessed 02 Sep 2019.
- 18.IQVIA. The impact of biosimilar competition in Europe. 2018. https://ec.europa.eu/docsroom/documents/31642. Accessed 02 Sep 2019.
- 19.United States Food and Drug Administration. Retacrit: Prescribing Information. 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125545s003lbl.pdf. Accessed 02 Sep 2019.
- 20.Pharmaceuticals and Medical Devices Agency. New drugs approved in FY 2018. https://www.pmda.go.jp/files/000229856.pdf. Accessed 02 Sep 2019.
- 21.Pharmaceuticals and Medical Devices Agency. New drugs approved in FY 2017. https://www.pmda.go.jp/files/000229079.pdf. Accessed 02 Sep 2019.
- 22.Generics and Biosimilars Initiative. Biosimilars approved in South Korea. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea. Accessed 02 Sep 2019.
- 23.Health Canada. Product monograph including patient medication information: Truxima (submission control no: 227399). 2019. https://pdf.hres.ca/dpd_pm/00052298.PDF. Accessed 02 Sep 2019.
- 24.Health Canada. Product monograph including patient medication information: Truxima (submission control no: 208204). 2019. https://pdf.hres.ca/dpd_pm/00050545.PDF. Accessed 02 Sep 2019.
- 25.Health Canada. Product monograph including patient medication information: Ogivri. 2019. https://pdf.hres.ca/dpd_pm/00051011.PDF. Accessed 02 Sep 2019.
- 26.Health Canada. Product monograph including patient medication information: Mvasi. 2019. https://pdf.hres.ca/dpd_pm/00051712.PDF. Accessed 02 Sep 2019.
- 27.Health Canada. Product monograph including patient medication information: Zirabev. 2019. https://pdf.hres.ca/dpd_pm/00051821.PDF. Accessed 02 Sep 2019.
- 30.United States Food and Drug Administration. Biological product definitions. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM581282.pdf. Accessed 02 Sep 2019.
- 31.United States Food and Drug Administration. Biosimilar product regulatory review and approval. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM581309.pdf. Accessed 02 Sep 2019.
- 34.European Medicines Agency. Guideline on immunogenicity assessment of therapeutic proteins. 2017. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf. Accessed 02 Sep 2019.
- 35.European Medicines Agency. Guideline on similar biological medicinal products containing biotechology-derived proteins as active substance: non-clinical and clinical issues (Rev1). 2014. https://www.ema.europa.eu/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf. Accessed 02 Sep 2019.
- 36.United States Food and Drug Administration. Guidance for industry: E9 statistical principles for clinical trials. 1998. https://www.fda.gov/media/71336/download. Accessed 02 Sep 2019.
- 37.European Medicines Agency. Note for guidance on statistical principles for clinical trials. 1998. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-9-statistical-principles-clinical-trials-step-5_en.pdf. Accessed 02 Sep 2019.
- 38.European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies—non-clinical and clinical issues. 2012. https://www.ema.europa.eu/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical_en.pdf. Accessed 02 Sep 2019.
- 40.Thatcher N, Thomas M, Paz-Ares L, Ostoros G, Pan Z, Goldschmidt JH et al. Randomized, double-blind, phase 3 study evaluating efficacy and safety of ABP 215 compared with bevacizumab in patients with non-squamous NSCLC. J Clin Oncol 2016;34(15 Suppl.):Abstract 9095. https://doi.org/10.1200/jco.2016.34.15_suppl.9095.CrossRefGoogle Scholar
- 41.European Medicines Agency. Mvasi: EPAR - Public assessment report. EMA/798844/2017. 2017. https://www.ema.europa.eu/documents/assessment-report/mvasi-epar-public-assessment-report_en.pdf. Accessed 02 Sep 2019.
- 42.von Minckwitz G, Colleoni M, Kolberg HC, Morales S, Santi P, Tomasevic Z, et al. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2018;19(7):987–98. https://doi.org/10.1016/S1470-2045(18)30241-9.CrossRefGoogle Scholar
- 43.Stebbing J, Baranau Y, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017;18(7):917–28. https://doi.org/10.1016/S1470-2045(17)30434-5.CrossRefPubMedGoogle Scholar
- 44.Rugo HS, Barve A, Waller CF, Hernandez-Bronchud M, Herson J, Yuan J, et al. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer: a randomized clinical trial. JAMA. 2017;317(1):37–47. https://doi.org/10.1001/jama.2016.18305.CrossRefPubMedGoogle Scholar
- 45.Pivot X, Bondarenko I, Nowecki Z, Dvorkin M, Trishkina E, Ahn JH, et al. Phase III, randomized, double-blind study comparing the efficacy, safety, and immunogenicity of SB3 (trastuzumab biosimilar) and reference trastuzumab in patients treated with neoadjuvant therapy for human epidermal growth factor receptor 2-positive early breast cancer. J Clin Oncol. 2018;36(10):968–74. https://doi.org/10.1200/JCO.2017.74.0126.CrossRefPubMedGoogle Scholar
- 46.Pegram M, Tan-Chui E, Freyman A, Vana A, Hilton F, Zacharchuk C et al. A randomized, double-blind study of PF-05280014 (a potential trastuzumab biosimilar) vs trastuzumab, both in combination with paclitaxel, as first-line treatment for HER2-positive metastatic breast cancer. Ann Oncol. 2017;28(Suppl. 5):Abstract 238PD. https://doi.org/10.1093/annonc/mdx365.001a.
- 47.European Medicines Agency. Trazimera: EPAR—Public assessment report. EMA/414095/2018. 2018. https://www.ema.europa.eu/documents/assessment-report/trazimera-epar-public-assessment-report_en.pdf. Accessed 02 Sep 2019.
- 48.Jurczak W, Moreira I, Kanakasetty GB, Munhoz E, Echeveste MA, Giri P, et al. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol. 2017;4(8):e350–61. https://doi.org/10.1016/S2352-3026(17)30106-0.CrossRefPubMedGoogle Scholar
- 49.Kim WS, Buske C, Ogura M, Jurczak W, Sancho JM, Zhavrid E, 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(8):e362–73. https://doi.org/10.1016/S2352-3026(17)30120-5.CrossRefPubMedGoogle Scholar
- 50.Ogura M, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan 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):e543–53. https://doi.org/10.1016/S2352-3026(18)30157-1.CrossRefPubMedGoogle Scholar
- 51.Park W, Bozic-Majstorovic L, Milakovic D, Berrocal Kasay A, El-Khouri EC, Irazoque-Palazuelos F, 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):934–43. https://doi.org/10.1080/19420862.2018.1487912.CrossRefPubMedPubMedCentralGoogle Scholar
- 52.Yoo DH, Suh CH, Shim SC, Jeka S, Cons-Molina FF, Hrycaj P, 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):566–70. https://doi.org/10.1136/annrheumdis-2016-209540.CrossRefPubMedPubMedCentralGoogle Scholar
- 53.European Medicines Agency. Truxima: EPAR—Public assessment report. EMEA/CHMP/75695/2017. 2016. https://www.ema.europa.eu/documents/assessment-report/truxima-epar-public-assessment-report_en.pdf. Accessed 02 Sep 2019.
- 54.United States Food and Drug Administration. Prescribing biosimilar products. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM581341.pdf. Accessed 03 Jun 2019.
- 57.Jørgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389(10086):2304–16. https://doi.org/10.1016/S0140-6736(17)30068-5.CrossRefPubMedGoogle Scholar
- 58.Blackwell K, Gascon P, Krendyukov A, Gattu S, Li Y, Harbeck N. Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2018;29(1):244–9. https://doi.org/10.1093/annonc/mdx638.CrossRefPubMedGoogle Scholar
- 59.Yao H-M, Ottery FD, Borema T, Harris S, Levy J, May TB, et al. PF-06881893 (Nivestym™), a filgrastim biosimilar, versus US-licensed filgrastim reference product (US-Neupogen®): pharmacokinetics, pharmacodynamics, immunogenicity, and safety of single or multiple subcutaneous doses in healthy volunteers. BioDrugs. 2019;33(2):207–20. https://doi.org/10.1007/s40259-019-00343-8.CrossRefPubMedPubMedCentralGoogle Scholar
- 60.Belleudi V, Trotta F, Addis A, Ingrasciotta Y, Ientile V, Tari M, et al. Effectiveness and safety of switching originator and biosimilar epoetins in patients with chronic kidney disease in a large-scale Italian cohort study. Drug Saf. 2019. https://doi.org/10.1007/s40264-019-00845-y.CrossRefPubMedGoogle Scholar
- 61.Thadhani R, Guilatco R, Hymes J, Maddux FW, Ahuja A. Switching from epoetin alfa (Epogen®) to epoetin alfa-epbx (RetacritTM) using a specified dosing algorithm: a randomized, non-inferiority study in adults on hemodialysis. Am J Nephrol. 2018;48(3):214–24. https://doi.org/10.1159/000492621.CrossRefPubMedPubMedCentralGoogle Scholar
- 63.Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, et al. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2016;1(6):e000142. https://doi.org/10.1136/esmoopen-2016-000142.CrossRefPubMedGoogle Scholar
- 64.La Noce A, Ernst M. Switching from reference to biosimilar products: an overview of the European approach and real-world experience so far. Eur Med J Rheumatol. 2018;3(3):74–81.Google Scholar
- 65.Welch AR. The Norwegian biosimilar phenomenon: from biosimilar to “biogeneric”. 2016. https://www.biosimilardevelopment.com/doc/the-norwegian-biosimilar-phenomenon-from-biosimilar-to-biogeneric-0001. Accessed 02 Sep 2019.
- 66.European Medicines Agency, European Commission. Biosimilars in the EU: information guide for healthcare professionals. 2017. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Accessed 02 Sep 2019.
- 67.United States Congress. Public Health Service Act. 2019. https://legcounsel.house.gov/Comps/PHSA-merged.pdf. Accessed 02 Sep 2019.
- 68.United States Food and Drug Administration. Considerations in demonstrating interchangeability with a reference product: guidance for industry. 2019. https://www.fda.gov/media/124907/download. Accessed 02 Sep 2019.
- 69.Cauchi R. State laws and legislation related to biologic medications and substitution of biosimilars. 2018. http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx. Accessed 02 Sep 2019.
- 70.American Society for Clinical Oncology. ASCO comment letter on ‘Considerations in demonstration interchangeability with a reference product, draft guidance for industry’. 2017. https://www.asco.org/sites/new-www.asco.org/files/content-files/Comments-Biosimilar-Interchangeability.pdf. Accessed 02 Sep 2019.
- 71.Government of Canada. Fact sheet: biosimilars. 2017. https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html. Accessed 02 Sep 2019.
- 72.Abraham I, Han L, Sun D, MacDonald K, Aapro M. Cost savings from anemia management with biosimilar epoetin alfa and increased access to targeted antineoplastic treatment: a simulation for the EU G5 countries. Future Oncol. 2014;10(9):1599–609. https://doi.org/10.2217/fon.14.43.CrossRefPubMedGoogle Scholar
- 73.Generics and Biosimilars Initiative. Biosimilars of epoetin alfa. 2018. http://www.gabionline.net/Biosimilars/General/Biosimilars-of-epoetin-alfa. Accessed 02 Sep 2019.
- 77.Big Molecule Watch. BPCIA litigations. 2019. https://www.bigmoleculewatch.com/bpcia-patent-litigations/. Accessed 02 Sep 2019.
- 78.Federal Trade Commission. Pay for delay. https://www.ftc.gov/news-events/media-resources/mergers-competition/pay-delay. Accessed 02 Sep 2019.
- 79.Congress.gov. S.2554—Patient Right to Know Drug Prices Act. 2018. https://www.congress.gov/bill/115th-congress/senate-bill/2554/text. Accessed 02 Sep 2019.
- 80.Faegre Baker Daniels. Biologic and biosimilar settlement agreements now must be disclosed to DOJ and FTC. 2018. https://www.faegrebd.com/en/insights/publications/2018/11/biologic-and-biosimilar-settlement-agreements-now-must-be-disclosed-to-doj-and-ftc. Accessed 02 Sep 2019.
- 82.Edgar T, Grosvenor A, Rademacher K. Biosimilar discounting and contracting: what can the US learn from Europe? 2018. https://www.biosimilardevelopment.com/doc/biosimilar-discounting-contracting-what-can-the-u-s-learn-from-europe-0001. Accessed 02 Sep 2019.
- 91.European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). 2014. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf. Accessed 02 Sep 2019.
- 92.European Medicines Agency. Mvasi: Summary of Product Characteristics. 2018. https://www.ema.europa.eu/documents/product-information/mvasi-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 93.United States Food and Drug Administration. Mvasi: Prescribing Information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761028s000lbl.pdf. Accessed 02 Sep 2019.
- 94.Mehr S. An update on potential biosimilars for bevacizumab. 2019. https://biosimilarsrr.com/2019/01/10/an-update-on-potential-biosimilars-for-bevacizumab/. Accessed 02 Sep 2019.
- 95.Staines R. Amgen and Allergan’s Avastin biosimilar could face EU delay. 2018. https://pharmaphorum.com/news/amgen-allergans-avastin-biosimilar-face-eu-delay/. Accessed 02 Sep 2019.
- 96.European Medicines Agency. Kanjinti: Summary of Product Characteristics. 2018. https://www.ema.europa.eu/documents/product-information/kanjinti-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 97.DiGrande S. Eye on pharma: Daiichi Sankyo launches biosimilar trastuzumab in Japan. 2018. https://www.centerforbiosimilars.com/news/eye-on-pharma-daiichi-sankyo-launches-biosimilar-trastuzumab-in-japan. Accessed 02 Sep 2019.
- 98.European Medicines Agency. Herzuma: Summary of Product Characteristics. 2019. https://www.ema.europa.eu/en/documents/product-information/herzuma-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 99.United States Food and Drug Administration. Herzuma: Prescribing Information. 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761091s000lbl.pdf. Accessed 02 Sep 2019.
- 100.The Investor. Bio & Medicine. Celltrion CEO aims to sell Truxima in US this year. 2019. http://www.theinvestor.co.kr/view.php?ud=20190326000692. Accessed 04 Sep 2019.
- 101.Mundipharma. Herzuma® (trastuzumab), a biosimilar for the treatment of breast cancer, now available in Europe. 2018. https://www.mundipharma.com/wp-content/uploads/2018/05/001-Herzuma-EU-availability-release-02052018.pdf. Accessed 02 Sep 2019.
- 102.United States Food and Drug Administration. Ogivri: Prescribing Information. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761074s000lbl.pdf. Accessed 02 Sep 2019.
- 103.European Medicines Agency. Ogivri: Summary of Product Characteristics. 2018. https://www.ema.europa.eu/en/documents/product-information/ogivri-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 104.Biosimilars Review and Report. Product Profile: trastuzumab-dkst (Ogivri). https://biosimilarsrr.com/product-profile-ogivri-2-2-2/. Accessed 02 Sep 2019.
- 105.European Medicines Agency. Trazimera: Summary of Product Characteristics. 2018. https://www.ema.europa.eu/documents/product-information/trazimera-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 106.United States Food and Drug Administration. Trazimera: Prescribing Information. 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf. Accessed 02 Sep 2019.
- 107.Mehr S. Pfizer signs licensing agreement with Roche on trastuzumab biosimilar. 2018. https://biosimilarsrr.com/2018/12/10/pfizer-signs-licensing-agreement-with-roche-on-trastuzumab-biosimilar/. Accessed 02 Sep 2019.
- 108.The Center for Biosimilars. Eye on pharma: Pfizer launches Trazimera in Spain. 2019. https://www.centerforbiosimilars.com/news/eye-on-pharma-pfizer-launches-trazimera-in-spain. Accessed 02 Sep 2019.
- 109.European Medicines Agency. Ontruzant: Summary of Product Characteristics. 2018. https://www.ema.europa.eu/documents/product-information/ontruzant-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 110.United States Food and Drug Administration. Ontruzant: Prescribing Information. 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761100s000lbl.pdf. Accessed 02 Sep 2019.
- 111.The Center for Biosimilars. First trastuzumab biosimilar launches in Europe. 2018. https://www.centerforbiosimilars.com/news/first-trastuzumab-biosimilar-launches-in-europe. Accessed 02 Sep 2019.
- 112.European Medicines Agency. Blitzima: Summary of Product Characteristics. 2018. https://www.ema.europa.eu/documents/product-information/blitzima-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 113.European Medicines Agency. Ritemvia: Summary of Product Characteristics. 2018. https://www.ema.europa.eu/documents/product-information/ritemvia-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 114.European Medicines Agency. Baraclude: Summary of Product Characteristics. 2018. https://www.ema.europa.eu/en/documents/product-information/baraclude-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 115.United States Food and Drug Administration. Truxima: Prescribing Information. 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761088s000lbl.pdf. Accessed 02 Sep 2019.
- 116.Southey F. Roche predicts US competition: MabThera, followed by Herceptin and Avastin 2018. https://www.biopharma-reporter.com/Article/2018/10/26/Roche-predicts-US-competition-MabThera-followed-by-Herceptin-and-Avastin. Accessed 02 Sep 2019.
- 117.Mundipharma. Mundipharma to launch Truxima®▼ (rituximab), the first biosimilar monoclonal antibody for the treatment of cancer, in seven European markets. 2017. https://www.mundipharma.com/wp-content/uploads/2017/09/170222_Truxima-Launch-Release.pdf. Accessed 13 May 2019.
- 118.European Medicines Agency. Rixathon: Summary of Product Characteristics. 2017. https://www.ema.europa.eu/documents/product-information/rixathon-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 119.European Medicines Agency. Riximyo: Summary of Product Characteristics. 2017. https://www.ema.europa.eu/en/documents/product-information/riximyo-epar-product-information_en.pdf. Accessed 02 Sep 2019.
- 120.McKee S. Sandoz launches MabThera, Enbrel biosimilars in the UK. 2017. http://www.pharmatimes.com/news/sandoz_launches_mabthera,_enbrel_biosimilars_in_the_uk_1197232. Accessed 02 Sep 2019.
- 122.Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non-Hodgkin’s lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17(4):1244. https://doi.org/10.1200/jco.19184.108.40.2064.CrossRefPubMedGoogle Scholar