References

ABPI. Understanding biological & biosimilar medicines. July 2014. Available from http://www.abpi.org.uk/our-work/library/medical-disease/Documents/understanding_biological_biosimilar_medicines.pdf (accessed 26 October, 2017).

Biosimilars Forum. Biosimilars - Frequently Asked Questions. Available at http://www.biosimilarsforum.org/sites/default/files/uploads/biosimilars_faqs_032816opt_0.pdf (accessed 26 October 2017).

BioWorld ‘Biosimilars: a global perspective of a new market” Available from: http://www.bioworld.com/sites/default/files/img/biosimilars2014_-_sample_0.pdf (accessed 26 October 2016).

Blackstone EA, Fuhr JP. The Economics of Biosimilars. Am Health Drug Benefits 2013;6:469–478.

Braun J,Kudrin A. Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health. Biologicals. 2016;44:257–66

Buffery D. Competition as an Incentive for Innovation. Am Health Drug Benefits. 2010;3: 27–8.

Calvo B, Zuñiga L. EU's new pharmacovigilance legislation: considerations for biosimilars. Drug Saf. 2014;37:9–18.

Casadevall N, Edwards IR, Felix T, Graze PR, Litten JB, Strober BE, et al. Pharmacovigilance and biosimilars: considerations, needs and challenges. Expert Opin Biol Ther 2013;13:1039–47.

Choy E, Jacobs IA. Biosimilar safety considerations in clinical practice. Semin Oncol 2014;41:S3–S14.

Declerck, PJ. Biologicals and biosimilars: a review of the science and its implications. Generics and Biosimilars Initiative Journal 2012;1:13–6.

Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. Exp Opin Biol Ther. 2012;12:1473–85.

Ebbers HC. Interchangeability. An insurmountable fifth hurdle? GaBI J 2014;3:88–93.

EMA 2013. Concept paper on extrapolation of efficacy and safety in medicine development. 19 March 2013, EMA/129698/2012. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142358.pdf (accessed 26 October 2017).

EMA 2015. Applying for EU marketing authorisation. For medicinal products for human use. Available from: www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2011/03/WC500104233.pdf (accessed 18 January 2018).

EMA 2018. Marketing authorisation. Available online at: www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001595.jsp&mid=WC0b01ac0580b18a3d#Steps involved in obtaining an EU marketing authorisation (accessed 18 January 2018).

EMA 2017. Biosimilars in the EU. Information guide for healthcare professionals. Available online at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp&mid=WC0b01ac0580bb8fda (accessed 26 October 2017).

European Commission. Consensus Information Paper 2013: What you Need to Know about Biosimilar Medicinal Products. http://www.medicinesforeurope.com/wp-content/uploads/2016/03/biosimilars_report_en.pdf (accessed 26 October 2017).

EvaluatePharma® World Preview 2015, Outlook to 2020. 8th Edition – June 2015. Available from http://info.evaluategroup.com/rs/607-YGS-364/images/wp15.pdf (accessed 26 October 2017).

FDA 1999. U.S. Department of Health and Human Services Food and Drug Administration (FDA) Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products Available online at: https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/blood/ucm080825.pdf (accessed 26 October 2017).

FDA 2014. U.S. Department of Health and Human Services Food and Drug Administration (FDA). CDER 21st Century Review Process. Desk Reference Guide. Available online at: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM218757.pdf (accessed 18 January 2018).

FDA 2015a. U.S. Department of Health and Human Services Food and Drug Administration (FDA). Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. April 2015. Available online at: https://www.fda.gov/ucm/groups/fdagov-public/documents/document/ucm291128.pdf (accessed 26 October 2017).

FDA 2015b. U.S. Department of Health and Human Services Food and Drug Administration (FDA). Frequently Asked Questions About Therapeutic Biological Products. Available online at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm (accessed on 18 January 2018).

FDA 2017a. U.S. Department of Health and Human Services Food and Drug Administration (FDA). Biological Product Definitions. 2017. Available online at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm (accessed 26 October 2017).

FDA 2017b. US Department of Health and Human Services Food and Drug Administration (FDA). 2017. Biosimilar Product Regulatory Review and Approval. Available online at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580429.htm (accessed 26 October 2017).

Flodmark CE, Lilja K, Woehling H, Järvholm K. Switching from reference product to biosimilar human growth hormone using dialogue teamwork: Single-center experience from Sweden. Biol Ther. 2013;3:35–43.

GaBi Online. Biosimilars approved in Europe. Oct 2017. Available online at: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe (accessed 26 October 2017).

GaBi. Biosimilars approved in the US. Sept 2017. Available online at: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US (accessed 26 October 2017).

Gascon P, Tesch H, Verpoort K, Rosati MS, Salesi N, Agrawal S, et al. Clinical experience with Zarzio® in Europe: what have we learned? Support Care Cancer 2013;21:2925–32.

Geist BJ, Davis D, McIntosh T, Yang TY, Goldberg K, Han C, et al. A novel approach for the simultaneous quantification of a therapeutic monoclonal antibody in serum produced from two distinct host cell lines. Mabs 2013;5:150–61.

IMS Institute for Healthcare Informatics. 2016a. Delivering on the Potential of Biosimilar Medicines. Available online at: http://www.medicinesforeurope.com/wp-content/uploads/2016/03/IMS-Institute-Biosimilar-Report-March-2016-FINAL.pdf (accessed 26 October 2017).

IMS Institute for Healthcare Informatics. 2016b Medicines Use and Spending in the US. A review of 2015 and Outlook to 2020. Available online at: http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports/medicines-use-and-spending-in-the-us-a-review-of-2015-and-outlook-to-2020#form (accessed 26 October 2017).

International Alliance of Patients’ Organizations (IAPO). Briefing Paper on Biological and Biosimilar Medicines. 2013. Available from https://www.iapo.org.uk/sites/default/files/files/IAPO%20Briefing%20Paper.pdf (accessed 26 October 2017).

International Conference on Harmonisation. ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process 2004. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf (accessed 26 October 2017).

Jacobs I, Ewesuedo R, Lula S, Zacharchuk C. Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence. Biodrugs. 2017;31:1–36.

Jacoby R, Pernenkil L, Harutunian S, Heim M, Sabad A. Advanced Biopharmaceutical Manufacturing: An Evolution Underway. Deloitte Consulting LLP. 2015;1–16. Available online at: https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life-sciences-health-care/us-lshc-advanced-biopharmaceutical-manufacturing-white-paper-051515.pdf (accessed 26 October 2017).

Johnson S, Gunderson B, Bowen K, Staarner CI, Gleason PP. Specialty Drugs Are Forecasted To Be 50% of All Drug Expenditures in 2018 [abstract no 612.777.5072]. Journal of Managed Care Pharmacy 2013:19.

Kelly C, Mir F. Biological therapies: how can we afford them? BMJ (online) 2009;339:666–669.

Kurki P, Bielsky MC et al. ECCO position challenged by European drug regulators. J Crohns Colitis 2014;8:258.

Kurki P. Biosimilars for prescribers. GaBI J. 2015;4:33–5.

Lee LY, Garland SM. Human papillomavirus vaccination: the population impact. F1000Res 2017; 6:866.

Lee YH, Bae SC. Comparative efficacy and safety of tocilizumab, rituximab, abatacept and tofacitinib in patients with active rheumatoid arthritis that inadequately responds to tumor necrosis factor inhibitors: a Bayesian network meta-analysis of randomized controlled trials. Int J Rheum Dis 2016;19:1103–11.

Lonnemann G, Wrenger E. Biosimilar epoetin zeta in nephrology - a single-dialysis center experience. Clin Nephrol. 2011;75:59–62.

McCamish M, Gallagher AM, Orloff J. Biosimilar by name and biosimilar by nature. Elsevier Business Intelligence Report. July/August 2013. Available online at: https://www.sandoz.com/sites/www.sandoz.com/files/rpm-report.pdf (accessed 26 October 2017).

McCamish M, Woollett G. The continuum of comparability extends to biosimilarity: how much is enough and what clinical data are necessary? Clin Pharmacol Ther. 2013;93:315–7.

McCamish M, Woollett G. The State of the Art in the Development of Biosimilars. Clin Pharmacol Ther 2012;91:405–17.

McCamish M, Pakulski J,Sattler C, Woollett G. Toward interchangeable biologics. Clin Pharmacol Ther 2015:97:215–7.

McCamish M, Yoon W, McKay J. Biosimilars: Biologics That Meet Patients’ Needs and Healthcare Economics. Am J Manag Care. 2016;22:S439–S442.

MHLW. Guidelines for the Quality, Safety and Efficacy Assurance of Follow-On Biologics; Tokyo, Japan, 2009. Available from: http://www.pmda.go.jp/files/000153851.pdf#page=1 (accessed 26 October 2017).

Miltenburger C, Günther OH, Justo N, Karampampa K, Texier-Richard B, Schweikert B. Barriers to RA treatment access across Europe (2009). Available from: http://www.comparatorreports.se/RA%20Barrier%20Report_FINAL_050110.pdf (accessed 26 October 2017).

Ministry of Health. Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs); Health Canada: Ottawa, Canada, 2010. Available from http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu_2010-eng.php (accessed 26 October 2017).

Monk BJ, Huh WK, Rosenberg JA, Jacobs I. Will bevacizumab biosimilars impact the value of systemic therapy in gynecologic cancers? Gynecol Oncol Res Pract. 2017;21;4:7.

Morrow T,Felcone LH. Defining the difference: What Makes Biologics Unique. Biotechnol Healthc 2004; 1: 24–26,28–29.

Mulcahy AW, Predmore Z, Mattke S. The RAND corporation: Perspectives: The Cost Savings Potential of Biosimilar Drugs in the United States, 2014 Available from: https://www.rand.org/pubs/perspectives/PE127.html (accessed 26 October 2017).

Nast A, Mrowietz U, Kragball K, de Jong EMGJ, Puig L, Reich K, Warren RB, et al. Barriers to the prescription of systemic therapies for moderate-to-severe psoriasis--a multinational cross-sectional study. Arch Dermatol Res 2013;305:899–907.

National Cancer Institute. Biological therapies for cancer. 2013. Available online at: https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/bio-therapies-fact-sheet (accessed 26 October 2017).

Olech W. Biosimilars: Rationale and current regulatory landscape. Semin Arthritis Rheum 2016;45:S1–10.

Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Ureña S, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis. 2017;76:346–354.

PHARMAC. Annual Review 2014. Available online at: https://www.pharmac.govt.nz/assets/annual-review-2014.pdf (accessed 26 October 2017).

Putrik P, Ramiro S, Kvien TK, Sokka T, Pavlova M, Uhlig T, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries Ann Rheum Dis 2014;73:198–206.

Quintiles IMS. Disruption and maturity: the next phase of biologics. 2017. Available online at: https://www.iqvia.com/-/media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next_phase_of_biologics.pdf?_=1511170765703 (accessed 26 October 2017).

Rashid N, Saenger P, Wu Y-L, Woehling H, Frankel M, Lifshitz F et al. Switching to Omnitrope® from other recombinant human growth hormone therapies: A retrospective study in an integrated healthcare system. Biol Ther. 2014;4:27–39.

Rugo HS, Linton KM, Cervi P, Rosenberg JA, Jacobs I. A clinician’s guide to biosimilars in oncology. Cancer Treat Rev 2016;46:73–9.

Schiestl M, Stangler T, Torella C, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011;29:310–2

Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013;72:315–8.

Stein KR, Pearce DJ, Feldman SR. The impact of biologics on the quality of life of psoriasis patients and the economics of psoriasis care. Semin Cutan Med Surg 2005;24:52–7.

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:e000142.

TGA. Regulation of Biosimilar Medicines v02, December 2015. Available from: https://www.tga.gov.au/publication/evaluation-biosimilars (accessed 26 October 2017).

Vermeer NS, Straus SM, Mantel-Teeuwisse AK, Domergue F, Egberts TC, Leufkens HG, et al. Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases. Drug Saf. 2013;38:617–25.

Vezér B, Buzás S, Sebeszta M, Zrubka Z. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents, Curr Med Res Opin 2016;32:829–834.

Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al. Biosimilars: what clinicians should know. Blood 2012;120:5111–7.

Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124:3191–6.

╚ęcek A, Ahmed I, Scigalla P, Koytchev R. Switching epoetin alfa and epoetin zeta in patients with renal anemia on dialysis: Posthoc analysis. Adv Ther. 2010;27:941–52.

Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis. 2017;76:355–363.

Zalai D, Dietzsch C, Herwig C.Risk-based process development of biosimilars as part of the quality by design paradigm. PDA J Pharm Sci Tech 2013;67:569–80.

Zelenetz AD. Biosimilars in Oncology. Oncology & Hematology Review 2016;12:22–8.

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The Biosimilars in Oncology Knowledge Centre provides healthcare professionals with up-to-date medical information and resources to improve their understanding of biosimilars.

Biological Medicines

Biological Medicines

What are biological and biosimilar medicines? Discover more about their development, as well as the manufacturing and regulatory processes here.

Biosimilars

Biosimilars

Biosimilars are molecular versions of existing reference biologics that have lost exclusivity. Find out how biosimilars are evaluated to ensure they match the reference medicine here.

Glossary & Resources

Glossary & Resources

Get a clear understanding of the various scientific terms used throughout the knowledge centre and further your knowledge of biosimilars through external societies and organisations.