Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation

Journal of Clinical Pharmacology

Volumn 55, Issue S3, 2015, Pages S123-S132

  Scott, Bradley J ^a   Klein, Agnes V ^a   Wang, Jian ^a  

^a Health Canada and World Health Organization Collaborating Center for Standardization and Evaluation of Biologicals   (Canada)

Author keywords

biologics; biosimilars; biotechnology; clinical trials; monoclonal antibodies; regulatory

Indexed keywords

BIOSIMILAR AGENT; INFLIXIMAB; MONOCLONAL ANTIBODY; NEW DRUG;

ARTICLE; BIOEQUIVALENCE; CANADA; CLINICAL ASSESSMENT; DRUG ABSORPTION; DRUG ANALYSIS; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG EXCRETION; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG METABOLISM; DRUG SAFETY; EUROPEAN MEDICINES AGENCY; EXPIRATION DATE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; MAXIMUM PLASMA CONCENTRATION; POSTMARKETING SURVEILLANCE; RISK ASSESSMENT; TREATMENT DURATION; THERAPEUTIC EQUIVALENCE;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; CANADA; DRUG APPROVAL; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; THERAPEUTIC EQUIVALENCY;

EID: 84923353114     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.339     Document Type: Article

References (45)

1. Leavy O,. Therapeutic antibodies: past, present and future. Nat Rev Immunol. 2010; 10 (5): 297. doi: 10.1038/nri2763.
2. European public assessment report for remsima (infliximab) EMA/407240/2013 EMEA/H/C/002576. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002576/human-med-001682.jsp&mid=WC0b01ac058001d124. Updated October 2013. Accessed February 10, 2014.
3. European Medicines Agency. European public assessment report for inflectra (infliximab) EMA/402688/2013 EMEA/H/C/002778. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002778/human-med-001677.jsp&mid=WC0b01ac058001d124. Updated October 2013. Accessed February 10, 2014.
4. Biocad. A safety and efficacy study of BCD-022 with paclitaxel compared to herceptin with paclitaxel in HER2-positive metastatic breast cancer patients. http://clinicaltrials.gov/ct2/show/NCT01764022?term=biosimilar&rank=24. Updated 2014. Accessed February 10, 2014.
5. Biocad. A safety and efficacy study of BCD-021 with paclitaxel and carboplatin compared to avastin with paclitaxel and carboplatin in non-small cell lung cancer. http://clinicaltrials.gov/ct2/show/NCT01763645?term=biosimilar&rank=25. Updated 2014. Accessed February 10, 2014.
6. Sandoz International GmbH., Study to demonstrate equivalent efficacy and to compare safety of Biosimilar Adalimumab (GP2017) and humira (ADACCESS). http://clinicaltrials.gov/ct2/show/NCT02016105?term=biosimilar&rank=6. Updated 2014. Accessed February 10, 2014.
7. Sandoz International GmbH. GP2013 in the treatment of patients with previously untreated, advanced stage follicular lymphoma http://clinicaltrials.gov/ct2/show/NCT01419665?term=biosimilar&rank=14. Updated 2011. Accessed February 10, 2014, 2014.
8. Celltrion. Demonstrate the equivalence of CT-P10 to MabThera with respect to the pharmacokinetic profile in patients with rheumatoid arthritis (triad RA). http://clinicaltrials.gov/ct2/show/NCT01534884?term=biosimilar&rank=17. Updated 2013. Accessed February 10, 2014.
9. Pfizer Inc. A pharmacokinetic study comparing PF-06439535 and bevacizumab in healthy male volunteers (REFLECTIONS B739-01). http://clinicaltrials.gov/ct2/show/NCT02031991?term=biosimilar&rank=10. Updated 2014. Accessed February 10, 2014.
10. Samsung Bioepis Co. L., A study comparing SB2 to remicade® in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy. http://clinicaltrials.gov/ct2/show/NCT01936181?term=biosimilar&rank=4. Updated 2013. Accessed February 10, 2014.
11. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study. Ann Rheum Dis. 2013; 72 (10): 1613-1620. doi: 10.1136/annrheumdis-2012-203090.
12. Elgert K,. Antibody structure and function. In: Immunology: Understanding the immune system, 2nd edition. Wiley; 1998:58-76. http://www.wiley.com/legacy/products/subject/life/elgert/CH04.pdf. Accessed February 10, 2014.
13. Breedveld F,. Therapeutic monoclonal antibodies. The Lancet. 2000; 355 (9205): 735-740. doi: http://dx.doi.org/10.1016/S0140-6736(00)01034-5.
14. Abès R, Teillaud J,. Impact of glycosylation on effector functions of therapeutic IgG. Pharmaceuticals. 2010; 3 (1): 146-157.
15. Spearman M, Dionne B, Butler M,. The role of glycosylation in therapeutic antibodies. In:, Al-Rubeai M, ed. Vol 7. Springer, Netherlands; 2011: 251-292. http://dx.doi.org/10.1007/978-94-007-1257-7-12. 10.1007/978-94-007-1257-7-12.
16. Aapro MS,. What do prescribers think of biosimilars ? Target Oncol. 2012; 7 (Suppl 1): S51-5. doi: 10.1007/s11523-011-0193-6.
17. Danese S, Gomollon F, Governing Board and Operational Board of ECCO. ECCO position statement: The use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013; 7 (7): 586-589. doi: 10.1016/j.crohns.2013.03.011.
18. Devlin SM, Bressler B, Bernstein CN,. Overview of subsequent entry biologics for the management of inflammatory bowel disease and canadian association of gastroenterology position statement on subsequent entry biologics. Can J Gastroenterol. 2013; 27 (10): 567-571.
19. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing monoclonal antibodies-non-clinical and clinical issues EMA/CHMP/BMWP/403543/2010. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2012/06/WC500128686.pdf. Updated 2012. Accessed February 10, 2014.
20. Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues EMEA/CHMP/BMWP/42832/2005. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003920.pdf. Updated 2006. Accessed February 10, 2014.
21. Health Canada. Guidance for sponsors: Information and submission requirements for subsequent entry biologics (SEBs). http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.php. Updated 2010. Accessed February 10, 2014.
22. Health Canada. Summary basis of decision (SBD) for inflectra. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd-smd-2014-inflectra-159493-eng.php. Published 2014. Updated 2014. Accessed May 8, 2014.
23. W.S. Putnam, S. Prabhu, Y. Zheng, M. Subramanyam, Y.C. Wang, Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies Trends Biotechnol. 28 10 2010; 509-516. doi: http://dx.doi.org/10.1016/j.tibtech.2010.07.001.
24. Hinton PR, Xiong JM, Johlfs MG, Tang MT, Keller S, Tsurushita N,. An engineered human IgG1 antibody with longer serum half-life. J Immunol. 2006; 176 (1): 346-356.
25. Wang W, Lu P, Fang Y, et al. Monoclonal antibodies with identical fc sequences can bind to FcRn differentially with pharmacokinetic consequences. Drug Metab Dispos. 2011; 39 (9): 1469-1477. doi: 10.1124/dmd.111.039453.
26. Casadevall N, Nataf J, Viron B, et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med. 2002; 346 (7): 469-475. http://dx.doi.org/10.1056/NEJMoa011931. doi: 10.1056/NEJMoa011931.
27. Steenholdt C, Svenson M, Bendtzen K, Thomsen OØ, Brynskov J, Ainsworth MA,., Severe infusion reactions to infliximab: Aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011; 34 (1): 51-58. doi: 10.1111/j.1365-2036.2011.04682.x.
28. Maas C, Hermeling S, Bouma B, Jiskoot W, Gebbink MF,. A role for protein misfolding in immunogenicity of biopharmaceuticals. J Biol Chem. 2007; 282 (4): 2229-2236. doi: 10.1074/jbc.M605984200.
29. Jahn EM, Schneider CK,. How to systematically evaluate immunogenicity of therapeutic proteins-regulatory considerations. N Biotechnol. 2009; 25 (5): 280-286. doi: 10.1016/j.nbt.2009.03.012.
30. Perdriger A,. Infliximab in the treatment of rheumatoid arthritis. Biologics. 2009; 3: 183-191.
31. Ducourau E, Mulleman D, Paintaud G, et al. Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases. Arthritis Res Ther. 2011; 13 (3): R105. doi: 10.1186/ar3386.
32. Brinks V,., Immunogenicity of biosimilar monoclonal antibodies. Generics and Biosimilars Initiative Journa (GaBI Journal). 2013; 2 (4): Epub ahead of print. doi: 10.5639/gabij.2013.0204.052.
33. Pascual-Salcedo D, Plasencia C, Ramiro S, et al. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology. 2011. doi: 10.1093/rheumatology/ker124.
34. Brennan FR, Morton LD, Spindeldreher S, et al. Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies mAbs. 2010; 2 (3): 233-255. http://www.landesbioscience.com/journals/mabs/article/11782/.
35. Committee for Medicinal Products for Human Use. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use EMA/CHMP/BMWP/86289/2010. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2012/06/WC500128688.pdf. Updated 2012. Accessed February 10, 20144.
36. Cai XY, Wake A, Gouty D,. Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development. Bioanalysis. 2013; 5 (5): 517-520. doi: 10.4155/bio.13.1.
37. Hobbs KF, Cohen MD,., Rheumatoid arthritis disease measurement: A new old idea. Rheumatology (Oxford). 2012; 51 (Suppl 6): vi21-7. doi: 10.1093/rheumatology/kes282.
38. Chan AC, Carter PJ,., Therapeutic antibodies for autoimmunity and inflammation. Nat Rev Immunol. 2010; 10 (5): 301-316. doi: 10.1038/nri2761.
39. Kaymakcalan Z, Sakorafas P, Bose S, et al. Comparisons of affinities, avidities, and complement activation of adalimumab, infliximab, and etanercept in binding to soluble and membrane tumor necrosis factor. Clinical Immunology. 2009; 131 (2): 308-316. doi: http://dx.doi.org/10.1016/j.clim.2009.01.002.
40. Mitoma H, Horiuchi T, Tsukamoto H, et al. Mechanisms for cytotoxic effects of anti-tumor necrosis factor agents on transmembrane tumor necrosis factor alpha-expressing cells: Comparison among infliximab, etanercept, and adalimumab. Arthritis Rheum. 2008; 58 (5): 1248-1257. doi: 10.1002/art.23447.
41. Tilg H, Moschen A, Kaser A,. Mode of function of biological anti-TNF agents in the treatment of inflammatory bowel diseases. Expert Opin Biol Ther. 2007; 7 (7): 1051-1059. doi: 10.1517/14712598.7.7.1051.
42. Van den Brande JM, Koehler TC, Zelinkova Z, et al. Prediction of antitumour necrosis factor clinical efficacy by real-time visualisation of apoptosis in patients with crohn's disease. Gut. 2007; 56 (4): 509-517. doi: gut.2006.105379 [pii].
43. Li J, Zhi J, Wenger M, et al. Population pharmacokinetics of rituximab in patients with chronic lymphocytic leukemia. J Clin Pharmacol. 2012; 52 (12): 1918-1926. doi: 10.1177/0091270011430506.
44. Hoffman-La Roche Ltd. Product monograph: Rituxan (rituximab). http://webprod5.hc-sc.gc.ca/dpd-bdpp/dispatch-repartition.do?lang=eng. Updated 2013. Accessed February 10, 2014.
45. Kay J, Feagan BG, Guirguis MS, et al. Health Canada/BIOTECanada summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), ottawa, canada, 14 may 2012. Biologicals. 2012; 40 (6): 517-527. doi: 10.1016/j.biologicals.2012.09.010.