Rituximab and biosimilars – equivalence and reciprocity

References

• Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predetermined specificity. Nature. 1975;256:495–497.
   PubMed Web of Science ®Google Scholar
• Schwaber J, Cohen EP. Human x mouse somatic cell hybrid clone secreting immunoglobulins of both parental types. Nature 1973;244(5416):444–447.
   PubMed Web of Science ®Google Scholar
• Freysd’ottir J. Production of monoclonal antibodies. Methods Mol Med. 2000;40:267–279.
   Google Scholar
• Stern M, Herrmann R. Overview of monoclonal antibodies in cancer therapy: present and promise. Crit Rev Oncol Hematol. 2005;54(1):11–29.
   PubMed Web of Science ®Google Scholar
• Dillman RO. Monoclonal antibodies for treating cancer. Annals Int Med. 1989;111(7):592–603.
   Web of Science ®Google Scholar
• 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(6):1927–1932.
   PubMed Web of Science ®Google Scholar
• Sanz I. Indications of rituximab in autoimune diseases. Drug Discov Today Ther Strateg. 2009;6(1):13–19.
   Google Scholar
• Rituximab [prescribing information]. Available from: http://www. accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf. Accessed April 4, 2013.
   Google Scholar
• EPAR Summary for the Public (MabThera). Available from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Sum- mary_for_the_public/human/000165/WC500025815.pdf. Accessed April 4, 2013.
   Google Scholar
• The Patient Protection and Affordable Care Act. Available from: http://www.gpo.gov/fdsys/pkg/BILLS-111hr3590enr/pdf/BILLS- 111hr3590enr.pdf. Accessed April 4, 2013.
   Google Scholar
• www.fda.gov [homepage on the Internet]. Biosimilars. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrug- sareDevelopedandApproved/ApprovalApplications/TherapeuticBio- logicApplications/Biosimilars/default.htm. Accessed April 4, 2013.
   Google Scholar
• Emerging health care issues: follow-on biologic drug competition. Washington, DC: Federal Trade Commission, 2009. Available from: http://www.ftc.gov/os/2009/06/P083901biologicsreport.pdf. Accessed April 4, 2013.
   Google Scholar
• Simoens S. Biosimilar medicines and cost effectiveness. Clinicoecon Outcomes Res. 2011;3:29–36.
   PubMedGoogle Scholar
• Hackbarth GM, Crosson FJ, Miller ME. Report of the Congress: improving incentives in the Medicare program. Washington, DC: Medicare Payment Advisory Commission; 2009.
   Google Scholar
• Guideline on similar biological medicinal products. London: European Medicines Agency, 2005. Available from: http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf. Accessed April 4, 2013.
   Google Scholar
• Committee for Medicinal Products for Human Use. Available from: http://www.emea.europa.eu/docs/en_GB/document_library/Sci- entific_guideline/2009/09/WC500003517.pdf. Accessed April 4, 2013.
   Google Scholar
• First biosimilar drug gets EU market authorization. Available from: http://www.euractiv.com/health/biosimilar-drug-gets-eu-market-a- news-216541. Accessed April 4, 2013.
   Google Scholar
• Issuance of Three Draft Guidance Documents on Biosimilar Product Development. Available from: http://www.fda.gov/Drugs/Developmen- tApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalAp- plications/TherapeuticBiologicApplications/Biosimilars/ucm291186. htm. Accessed April 4, 2013.
   Google Scholar
• Current and future issues surrounding biosimilars. Available from: http://www.gabionline.net/Biosimilars/Research/Current-and-future- issues-surrounding-biosimilars. Accessed April 4, 2013.
   Google Scholar
• Dr Reddy’s looks to biosimilars for growth. Available from: http://www.gabionline.net/layout/set/print/content/view/full/1779. Accessed April 4, 2013.
   Google Scholar
• www.drugregulations.org [homepage on the Internet]. New Indian Guidelines on Biosimilars. Available from: http://www.drugregulations. org/2012/10/new-indian-guidelines-on-biosimilars.html. Accessed April 4, 2013.
   Google Scholar
• Carey K. Biosimilars encircle Rituxan, U S debates innovator exclusivity. Nat Biotech. 2011;29,177–178.
   Web of Science ®Google Scholar
• Indian biosimilars market [webpage on the Internet]. Biosimilar News; 2011. Available from: http://www.biosimilarnews.com/ indian-biosimilars-market. Accessed January 14, 2013.
   Google Scholar
• Yang P. Roche – An Innovator s Perspective and Position on Biosimilars. Basel, Switzerland: Roche. Available from: http://www.roche.com/ irp101005.pdf. Accessed November 17, 2012.
   Google Scholar
• Hennessy S, Leonard CE, Platt R. Assessing the safety and comparative effectiveness of follow-on biologics (biosimilars) in the United States. Clin Pharmacol Ther. 2010;87(2):57–159.
   Web of Science ®Google Scholar
• Zuniga L, Calvo B. Biosimilars: pharmacovigilance and risk management. PharmacoepidemiolDrugSaf. 2010;19:661–669.
   PubMed Web of Science ®Google Scholar
• Biologics Working Party. Available from: http://www.ema.europa. eu/ema/index.jsp?curlsym-mpages/contacts/CHMP/people_list- ing_000009.jsp&midsym-mWC0b01ac0580028d2c. Accessed April 4, 2013.
   Google Scholar
• Biosimilar Medicinal Products Working Party. http://www.ema.europa. eu/ema/index.jsp?curlsym-mpages/contacts/CHMP/people_list- ing_000024.jsp
   Google Scholar
• Wiecek A, Mikhail A. European regulatory guidelines for biosimilars. Nephrol Dial Transplant. 2006;21(Suppl 5):v17–v20.
   PubMed Web of Science ®Google Scholar
• Gottlieb. Biosimilars: Policy, clinical, and regulatory considerations. Am JHealth-Syst Pharm. 2008;65(Suppl 6):S2–S8.
   Google Scholar
• Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res. 2007;30:267–272.
   PubMed Web of Science ®Google Scholar
• Crommelin D, Bermejo T, Bissig M, Damiaans J, Kramer I, et al. Pharmaceutical evaluation of biosimilars:important differences from generic low-molecular-weight pharmaceuticals. Euro J of Hospital Pharmacy Sci. 2005;11(1):11–17.
   Google Scholar
• US Department of Health and Human Services, Food and Drug Administration [FDA]. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Silver Spring, MD: FDA; May 2007. Available from: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf. Accessed November 18, 2012.
   Google Scholar
• Food and Drug Administration. Part 15 Public hearing on approval pathway for biosimilar and interchangeable biological products. Available from: http://www.fdalawyersblog.com/BiosimilarsNov3Transcript.pdf. Accessed April 4, 2013.
   Google Scholar
• Reichert JM. Next generation and biosimilar monoclonal antibodies. MAbs. 2011 May-Jun;3(3):223–240. Available from: http://www.ncbi. nlm.nih.gov/pmc/articles/PMC3149703. Accessed April 4, 2013.
   Google Scholar
• Roche Position on Similar Biological Medicinal Products. Available from: https://www.google.com/url?sasym-mt&rctsym-mj&qsym- m&esrcsym-ms&sourcesym-mweb&cdsym-m2&cadsym- mrja&vedsym-m0CD8QFjAB&urlsym-mhttp%3A%2F%2Fwww. roche.com%2Froche_position_biosimilars.pdf&eisym-mFII_UYzAJIGy8QTrnYDIBA&usgsym-mAFQjCNHPQYpMEgdTk7C- SiqyZWUeqxnOH6g&bvmsym-mbv.43287494,d.eWU. Accessed April 4, 2013.
   Google Scholar
• Fleming TR, Rothmann MD, Lu HL. Issues in using progression-free survival when evaluating oncology products. J Clin Oncol. 2009;27(17):2874–2880.
   PubMed Web of Science ®Google Scholar
• Wilkerson J, Fojo T. Progression-free survival is simply a measure of a drug’s effect while administered and is not a surrogate for overall survival. Cancer J. 2009;15(5):379–385.
   Web of Science ®Google Scholar
• Siegel JP. Clinical issues innovator industry presentation. EMEA workshop on biosimilar monoclonal antibodies. London: European Bio- pharmaceutical Enterprises; July 2, 2009. Available from: http://www. emea.europa.eu/docs/en_GB/document_library/Presentation/2009/11/ WC500008483.pdf. Accessed November 18, 2012.
   Google Scholar
• Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002;105:1135–1143.
   PubMed Web of Science ®Google Scholar
• Barnes PJ, Chowdhury B, Kharitonov SA, et al. Pulmonary biomarkers in chronic obstructive pulmonary disease. Am JRespir Crit Care Med. 2006;174(1):6–14.
   PubMed Web of Science ®Google Scholar
• Rossini A. Induction of immunologic tolerance for transplantation. Physiol Rev. 1999;79(1):99–141.
   PubMed Web of Science ®Google Scholar
• Kozlowski S, Woodcock J, Midthun K, Behrman Sherman R. Developing the nation’s biosimilars program. N Engl J Med. 2011;365(5):385–388.
   PubMed Web of Science ®Google Scholar
• Teva Pharmaceutical Industries. TL011 in severe, active rheumatoid arthritis patients. In: ClinicalTrials.gov [website on the Internet]. Bethesda, MD: US National Library of Medicine; 2010 [updated May 14, 2012]. Available from: http://www.clinicaltrials.gov/ct2/show/ NCT01123070. NLM identifier: NCT01123070. Accessed January 14, 2013.
   Google Scholar
• Sandoz. GP2013 in the treatment of RA patients refractory to or intolerant of standard therapy. In: ClinicalTrials.gov [website on the Internet]. Bethesda, MD: US National Library of Medicine; 2011 [updated November 11, 2011]. Available from: http://www.clinicaltrials.gov/ ct2/show/NCT01274182. NLM identifier: NCT01274182. Accessed January 14, 2013.
   Google Scholar
• Kay J. Biosimilars: a regulatory perspective from America. Arthritis Res Ther. 2011;13(3):112.
   Web of Science ®Google Scholar
• www.fda.gov [homepage on the Internet]. Available from: http://www. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291232. htm. Accessed on April 4, 2013.
   Google Scholar
• Carroll J. Everyone wants in, but with no ground rules, the biosimilar business remains elusive. Biotechnol Healthc. 2011;8(3):12–13.
   Google Scholar