IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG?
https://doi.org/10.17709/2409-2231-2016-3-2-6
Abstract
The possibility of extrapolation of indications for biosimilars is one of the issues widely discussed in modern literature. Currently, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have identified specific conditions under which for biosimilars extrapolation of indications is possible. In2015, athe first bioanalogue bevacizumab, (produced by JSC "BIOCAD"), has been registered. The article provides summary of the pivotal clinical study of Bevacizumab bioanalogue conducted in patients with non-small cell lung cancer. The article includes detailed scientific justification for the extrapolation of data on the efficacy, safety and immunogenicity obtained in the pivotal study to other indications, registered for the original bevacizumab drug.
About the Authors
S. V. Orlov
First Saint Petersburg State Medical University named after Academician I.P. Pavlov, Saint Petersburg
Russian Federation
Sergey V. Orlov – MD, PhD, prof., leading researcher of oncology department
Competing Interests: Орлов Сергей Владимирович – доктор медицинских наук, профессор, ведущий научный сотрудник отделения онкологии
Russian Federation
Sergey V. Orlov – MD, PhD, prof., leading researcher of oncology department
Competing Interests: Орлов Сергей Владимирович – доктор медицинских наук, профессор, ведущий научный сотрудник отделения онкологии
N. L. Shimanovskii
National Research Medical University named after N.I. Pirogov, Moscow
Russian Federation
Nikolay L. Shimanovskii – MD, PhD, prof., corresponding member of RAS, head of molecular pharmacology and radiobiology department named after academician P. V. Sergeev
Russian Federation
Nikolay L. Shimanovskii – MD, PhD, prof., corresponding member of RAS, head of molecular pharmacology and radiobiology department named after academician P. V. Sergeev
S. N. Fogt
BIOCAD JSCSaint Petersburg
Russian Federation
Russian Federation
Sergey N. Fogt – MD, PhD, medical advisor of second category, direction «Oncology»,
For correspondence: JSC «BIOCAD» Address: 34-A, ul. Svyazi, Strelna,Saint Petersburg, 198515, Russia E-mail: fogt@biocad.ru
References
1. Mulcahy Andrew W., Zachary Predmore and Soeren Mattke. The Cost Savings Potential of Biosimilar Drugs in the United States. Santa Monica, CA: RAND Corporation, 2014. http://www.rand. org/pubs/perspectives/PE127.html (Accessed: 11.03.2016).
2. EMA. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues [EMA/CHMP/BMWP/403543/2010]. 2012. 16 p. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2010/11/WC500099361.pdf (Accessed: 11.03.2016)
3. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues [EMEA/CHMP/ BMWP/42832/2005 Rev1]. 2014. 13 p. Available at: http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144124.pdf (Accessed: 11.03.2016)
4. FDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry. 2015. 22 p. Available at: http://www.fda.gov/ucm/groups/fdagov-public/documents/document/ucm291128.pdf (Accessed: 11.03.2016)
5. Gomollón F. Biosimilars: are they bioequivalent? Dig Dis. 2014; 32 (Suppl 1): 82–87. doi: 10.1159/000367833. Epub 2014 Dec 17.
6. Feagan B.G., Choquette D., Ghosh S., Gladman D.D. Ho V., Meibohm B., et al. The challenge of indication extrapolation for infliximab biosimilars. Biologicals. 2014; 42 (4): 177–183. doi: 10.1016/j.biologicals.2014.05.005. Epub 2014 Jun 21.
7. Subramanyam M. Clinical development of biosimilars: an evolving landscape. Bioanalysis. 2013; 5 (5): 575–586. doi: 10.4155/bio.13.5.
8. Socinski M. A. Curigliano G., Jacobs I., Gumbiner B., MacDonald J, Thomas D. Clinical considerations for the development of biosimilars in oncology. MAbs. 2015; 7 (2): 286–293. doi: 10.1080/19420862.2015.1008346.
9. Weise M., Bielsky M. C., De Smet K., Ehmann F., Ekman N., Giezen T.J., et al. Biosimilars: what clinicians should know. Blood. 2012; 120 (26): 5111–5117. doi: 10.1182/ blood 2012–04–425744. Epub 2012 Oct 23.
10. Orlov S. V., Fogt S.N., Shustova M. S. Successful registration of domestic bioanalogue of bevacizumab – new opportunities for effective treatment of patients with non-squamous cell nonsmall cell lung cancer. Research'n Practical Medicine Journal. 2015; 2 (4): 132–136. doi:10.17709/2409–2231–2015–2-4-132-136 (Russian).
11. Instrukcija po primeneniju lekarstvennogo preparata dlja medicinskogo primenenija Avastin® (ЛП 000533, 11.08.2015). (Russian).
12. Natsume A., Niwa R., Satoh M. Improving effector functions of antibodies for cancer treatment: Enhancing ADCC and CDC. Drug Des Devel Ther. 2009 Sep 21;3:7–16.
13. Mukherji S. K. Bevacizumab (Avastin). Am J Neuroradiol. 2010; 31: 235–236.
14. Alekseyev B.Ya., Kalpinsky A. S., Nyushko K. M., Klimenko A. A., Anzhiganova Yu. V., Varlamov S. A., et al. Identification of prognostic factors of the efficiency of bevacizumab therapy in patients with metastatic renal-cell cancer. Cancer Urology. 2013; 3: 17–23. (Russian).
15. Kim K.J., Li B., Winer J., Armanini M., Gillett N, Phillips HS, Ferrara N. Inhibition of vascular endothelial growth factor-induced angiogenesis suppresses tumour growth in vivo. Nature. 1993; 362 (6423): 841–844.
16. Ferrara N., Hillan K.J., Gerber H. P., Novotny W. Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer. Nat Rev Drug Discov. 2004; 3 (5): 391–400.
17. Sandler A., Gray R., Perry M. C., Brahmer J., Schiller JH, Dowlati A., et al. Paclitaxel-carboplatin alone or with bevacizumab for nonsmall-cell lung cancer. N Engl J Med. 2006; 355 (24): 2542–2550.
18. Giantonio B.J., Catalano P.J., Meropol N.J., O'Dwyer P.J., Mitchell EP, Alberts SR., et al. Bevacizumab in combination with oxaliplatin, fluorouracil, and leucovorin (FOLFOX4) for previously treated metastatic colorectal cancer: results from the Eastern Cooperative Oncology Group Study E3200. J Clin Oncol. 2007; 25 (12): 1539–1544.
19. Robert N.J., Diéras V., Glaspy J., Brufsky A. M., Bondarenko I, Lipatov ON., et al. RIBBON 1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2 negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011; 29 (10): 1252–1260.
20. Escudier B., Bellmunt J., Négrier S., Bajetta E. et al. Phase III trial of bevacizumab plus interferon alfa 2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival.J. Clin. Oncol. 2010; 28 (13): 2144–2150. doi: 10.1200/JCO.2010.28.0982. Epub 2011 Mar 7.
21. Pujade-Lauraine E., Hilpert F., Weber B. et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2004; 32: 1302=1308.
22. Tewari K. S., Sill M.W., Long H.J., Penson R. T., Huang H., Ramondetta L. M., et al. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014; 370 (8): 734–743. doi: 10.1056/NEJMoa1309748.
23. McKee A. E., Farrell A. T., Pazdur R., Woodcock J. The role of the U. S. Food and Drug Administration review process: clinical trial endpoints in oncology. Oncologist. 2010; 15 (Suppl 1): 13–18. doi: 10.1634/theoncologist.2010-S1–13.
24. George S. L. Response rate as an endpoint in clinical trials.J. Natl. Cancer Inst. 2007; 99: 98–99.
25. Clarke J. M., Wang X., Ready N. E. Surrogate clinical endpoints to predict overall survival in non-small cell lung cancer trials-are we in a new era? Transl Lung Cancer Res. 2015; 4 (6): 804–808. doi: 10.3978/j.issn.2218–6751.2015.05.03.
26. Johnson D.H., Fehrenbacher L., Novotny W. F., Herbst R. S., Nemunaitis J.J., Jablons D. M., et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2004; 22: 2184–2191.
27. Reck M., von Pawel J., Zatloukal P., Ramlau R., Gorbounova V., Hirsh V., et al. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol. 2009; 27 (8): 1227–1234. doi: 10.1200/JCO.2007.14.5466. Epub 2009 Feb 2.
28. Huang H., Zheng Y., Zhu J., Zhang J. Chen H., Chen X. An updated meta-analysis of fatal adverse events caused by bevacizumab therapy in cancer patients. PLoS ONE. 2014; 9 (3): e89960. doi: 10.1371/journal.pone.0089960.eCollection 2014.
29. Dai F., Shu L., Bian Y., Wang Z., Yang Z., Chu W., et al. Safety of bevacizumab in treating metastatic colorectal cancer: a systematic review and meta-analysis of all randomized clinical trials. Clin Drug Investig. 2013; 33 (11): 779–788.
30. Avastin. Full Prescribing information (U. S.). Revised 12/2015. Available at: http://www.gene.com/download/pdf/avastin_prescribing.pdf (Accessed: 11.03.2016)
Review
For citations:
Orlov S.V., Shimanovskii N.L., Fogt S.N. IS IT POSSIBLE TO USE BEVACIZUMAB BIOSIMILAR IN ALL INDICATIONS REGISTERED FOR ORIGINAL DRUG? Research and Practical Medicine Journal. 2016;3(2):45-52. (In Russ.) https://doi.org/10.17709/2409-2231-2016-3-2-6
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