4,873
Views
15
CrossRef citations to date
0
Altmetric
Report

International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab

, , , , , & show all
Pages 129-142 | Received 18 Jul 2017, Accepted 25 Sep 2017, Published online: 03 Nov 2017

References

  • Ecker DM, Jones SD, Levine HL. The therapeutic monoclonal antibody market. MAbs. 2015;7(1):9–14. doi:10.4161/19420862.2015.989042. PMID:25529996
  • Reichert JM. Metrics for antibody therapeutics development. MAbs. 2010;2(6):695–700. doi:10.4161/mabs.2.6.13603. PMID:20930555
  • European Medicines Agency. Medicines under evaluation by the Committee for Medical Products for Human Use (CHMP). 2017; Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/document_listing/document_listing_000349.jsp&mid=WC0b01ac05805083eb#section1 (Last accessed 13 June 2017).
  • Udpa N, Million RP. Monoclonal antibody biosimilars. Nat Rev Drug Discov. 2016;15(1):13–14 doi:10.1038/nrd.2015.12. PMID:26678619
  • Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178–9. doi:10.5639/gabij.2015.0404.040
  • McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91(3):405–417. doi:10.1038/clpt.2011.343. PMID:22318617
  • Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014;124(22):3191–3196. doi:10.1182/blood-2014-06-583617. PMID:25298038
  • Markus R, Liu J, Ramchandani M, Landa D, Born T, Kaur P. Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community. BioDrugs 2017;31(3):175–187. doi:10.1007/s40259-017-0218-5. PMID:28439817
  • Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013:72(3):315–318. doi:10.1136/annrheumdis-2012-202941. PMID:23390018
  • Vezer B, Buzas Z, 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(5):829–834. doi:10.1185/03007995.2016.1145579. PMID:26808864
  • Grampp G, Ramanan S. The Diversity of Biosimilar Design and Development: Implications for Policies and Stakeholders. BioDrugs. 2015;29(6):365–372. doi:10.1007/s40259-015-0147-0. PMID:26581551
  • Ramanan S, Grampp G. Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs. 2014;28(4):363–372. PMID:24567263
  • Beck A, Reichert JM. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry. MAbs. 2013:5(5):621–623. PMID:23924791
  • Nikolov NP, Shapiro MA. An FDA perspective on the assessment of proposed biosimilar therapeutic proteins in rheumatology. Nat Rev Rheumatol 2017;13(2):123–128. PMID:28053335
  • European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). 2012; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf.
  • US Food and Drug Administration. Guidance to Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product. 2015; Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
  • World Health Organization, Expert Committee on Biological Standardization. Fixty seventh report. Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs). 2017; WHO Technical Report series 1004:93-127. Available from: http://apps.who.int/iris/bitstream/10665/255657/1/9789241210133-eng.pdf
  • World Health Organization, Expert Committee on Biological Standardization. Fixty sixth report. Global needs in standardization of products derived by biotechnology. 2016; WHO Technical Report series. 999:13–15. Available from: http://www.who.int/biologicals/expert_committee/WHO_TRS_999_FINAL.pdf?ua=1
  • Wadhwa M, Kang HN, Knezevic I, Thorpe R, Griffiths E. WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010. Biologicals. 2011;39(5):349–357.
  • Thorpe R, Wadhwa M. Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars). Biologicals. 2011;39(5):262–265. PMID:21880508
  • World Health Organization, Expert Committee. The 19th WHO Model list of Essential Medicine. 2015; WHO Technical Report series 994:417–470. Available from: http://apps.who.int/iris/bitstream/10665/189763/1/9789241209946_eng.pdf.
  • Forstpointner R, Unterhalt M, Dreyling M, Bock HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hanel A, et al. Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006;108(13):4003–4008. PMID:16946304
  • Hiddemann W, Kneba M, Dreyling M, Schmitz N, Lengfelder E, Schmits R, Reiser M, Metzner B, Harder H, Hegewisch-Becker S, et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2005;106(12):3725–3732. doi:10.1182/blood-2005-01-0016. PMID:16123223
  • European Medicines Agency. MabThera: European Public Assessment report (EPAR)—Scientific Discussion. European Medicines Agency. 2005; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000165/WC500025817.pdf.
  • European Medicines Agency. MabThera: European Public Assessment report (EPAR)—Product information. 2016; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000165/WC500025821.pdf.
  • Dotan E, Aggarwal C, Smith MR. Impact of Rituximab (Rituxan) on the Treatment of B-Cell Non-Hodgkin's Lymphoma. P T. 2010:35(3):148–157. PMID:20442809
  • Sanz I. Indications of rituximab in autoimmune diseases. Drug Discov Today Ther Strateg. 2009;6(1):13–19. doi:10.1016/j.ddstr.2009.10.001. PMID:20379381
  • Jefferis R. Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action. Trends Pharmacol Sci. 2009;30(7):356–362. doi:10.1016/j.tips.2009.04.007. PMID:19552968
  • Glennie MJ, French RR, Cragg MS, Taylor RP. Mechanisms of killing by anti-CD20 monoclonal antibodies. Mol Immunol. 2007;44(16):3823–3837. doi:10.1016/j.molimm.2007.06.151. PMID:17768100
  • Smith MR. Rituximab (monoclonal anti-CD20 antibody): mechanisms of action and resistance. Oncogene. 2003;22(47):7359–7368. doi:10.1038/sj.onc.1206939. PMID:14576843
  • Jaglowski SM, Alinari L, Lapalombella R, Muthusamy N, Byrd JC. The clinical application of monoclonal antibodies in chronic lymphocytic leukemia. Blood. 2010;116(19):3705–3714. doi:10.1182/blood-2010-04-001230. PMID:20610811
  • World Health Organization, Expert Committee on Biological Standardization. Sixty fifth report. Proposed First WHO reference reagent for Rituximab for use in Complement dependent cytotoxicity assays. 2015; WHO Technical Report Series. 993:36–37. Available from: http://apps.who.int/iris/bitstream/10665/173739/1/9789240694095_eng.pdf
  • Wadhwa M, Bird C, Dilger P, Rigsby P, Jia H, Gross MEB, participants of the s. Establishment of the first WHO International Standard for etanercept, a TNF receptor II Fc fusion protein: Report of an international collaborative study. J Immunol Methods. 2017;447:14–22. doi:10.1016/j.jim.2017.03.007. PMID:28288790
  • Hubbard AR. Potency labeling of novel factor VIII and factor IX concentrates: past experience and current strategy. Semin Thromb Hemost. 2015;41(8):849–854. doi:10.1055/s-0034-1395353. PMID:25703515
  • Kirkwood TB. Predicting the stability of biological standards and products. Biometrics. 1977;33(4):736–742. doi:10.2307/2529472. PMID:588659
  • World Health Organization, Expert Committee on Biological Standardization.Fifty fifth report. Recommendations for the preparation, characterization and establishment of international and other biological reference standards. 2006; WHO Technical Report Series. 932:73–130. Available from: http://apps.who.int/iris/bitstream/10665/43278/1/WHO_TRS_932_eng.pdf.
  • Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol. 2011;29(4):310–312. doi:10.1038/nbt.1839. PMID:21478841
  • Cheng ZJ, Garvin D, Paguio A, Moravec R, Engel L, Fan F, Surowy T. Development of a robust reporter-based ADCC assay with frozen, thaw-and-use cells to measure Fc effector function of therapeutic antibodies. J Immunol Methods. 2014;414:69–81. doi:10.1016/j.jim.2014.07.010. PMID:25086226
  • Kellner C, Derer S, Valerius T, Peipp M. Boosting ADCC and CDC activity by Fc engineering and evaluation of antibody effector functions. Methods. 2014:65(1):105–113. doi:10.1016/j.ymeth.2013.06.036. PMID:23851282
  • Kim S, Song J, Park S, Ham S, Paek K, Kang M, Chae Y, Seo H, Kim HC, Flores M. Drifts in ADCC-related quality attributes of Herceptin(R): Impact on development of a trastuzumab biosimilar. MAbs. 2017;9(4):704–714. doi:10.1080/19420862.2017.1305530. PMID:28296619
  • Iida S, Misaka H, Inoue M, Shibata M, Nakano R, Yamane-Ohnuki N, Wakitani M, Yano K, Shitara K, Satoh M. Nonfucosylated therapeutic IgG1 antibody can evade the inhibitory effect of serum immunoglobulin G on antibody-dependent cellular cytotoxicity through its high binding to FcgammaRIIIa. Clin Cancer Res. 2006;12(9):2879–2887. doi:10.1158/1078-0432.CCR-05-2619. PMID:16675584
  • Preithner S, Elm S, Lippold S, Locher M, Wolf A, da Silva AJ, Baeuerle PA, Prang NS. High concentrations of therapeutic IgG1 antibodies are needed to compensate for inhibition of antibody-dependent cellular cytotoxicity by excess endogenous immunoglobulin G. Mol Immunol. 2006:43(8):1183–1193. doi:10.1016/j.molimm.2005.07.010. PMID:16102830
  • Chung S, Lin YL, Reed C, Ng C, Cheng ZJ, Malavasi F, Yang J, Quarmby V, Song A. Characterization of in vitro antibody-dependent cell-mediated cytotoxicity activity of therapeutic antibodies - impact of effector cells. J Immunol Methods. 2014;407:63–75 doi:10.1016/j.jim.2014.03.021. PMID:24704820
  • Hatjiharissi E, Xu L, Santos DD, Hunter ZR, Ciccarelli BT, Verselis S, Modica M, Cao Y, Manning RJ, Leleu X, et al. Increased natural killer cell expression of CD16, augmented binding and ADCC activity to rituximab among individuals expressing the Fc{gamma}RIIIa-158 V/V and V/F polymorphism. Blood. 2007:110(7):2561–2564. doi:10.1182/blood-2007-01-070656. PMID:17475906
  • Hsieh YT, Aggarwal P, Cirelli D, Gu L, Surowy T, Mozier NM. Characterization of FcgammaRIIIA effector cells used in in vitro ADCC bioassay: Comparison of primary NK cells with engineered NK-92 and Jurkat T cells. J Immunol Methods. 2017;441:56–66. PMID:27939300
  • Mata MM, Mahmood F, Sowell RT, Baum LL. Effects of cryopreservation on effector cells for antibody dependent cell-mediated cytotoxicity (ADCC) and natural killer (NK) cell activity in (51)Cr-release and CD107a assays. J Immunol Methods. 2014:406:1–9. doi:10.1016/j.jim.2014.01.017. PMID:24561308
  • European Medicines Agency. Committee for Medical Products for Human Use (CHMP). Assessment report, Remsima. 2013; EMA/CHMP/589317/2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf
  • Schiestl M, Li J, Abas A, Vallin A, Millband J, Gao K, Joung J, Pluschkell S, Go T, Kang HN. The role of the quality assessment in the determination of overall biosimilarity: a simulated case study exercise. Biologicals. 2014;42(2):128–132. doi:10.1016/j.biologicals.2013.11.009. PMID:24373974
  • Biosimilars of Rituximab. Generics and Biosimilars Initiative Journal (GaBI Online). Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab.
  • Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, Thirstrup S. Setting the stage for biosimilar monoclonal antibodies. Nat Biotechnol. 2012;30(12):1179–1185. doi:10.1038/nbt.2447. PMID:23222783
  • Bristow AF, Barrowcliffe T, Bangham DR. Standardization of biological medicines: the first hundred years, 1900-2000. Notes Rec R Soc Lond. 2006;60(3):271–289. doi:10.1098/rsnr.2006.0153. PMID:17212227
  • World Health Organization, Expert Committee on Biological Standardization. Sixty sixth report. Report of a WHO informal consultation on international standards for biotherapeutic products. 2016; WHO Technical Report series 999:13–15. Available from: http://apps.who.int/iris/bitstream/10665/208900/1/9789240695634-eng.pdf