Biyobenzer İlaçlar

Yıl 2020, Cilt: 13 Sayı: 2, 34 - 42, 09.04.2021

Çağla Küçük Özlem Ateş Duru , Esra Mutlu , Hande Kazak Sarilmiser

https://doi.org/10.20854/bujse.874593

Öz

Biyobenzer ilaçlar, saflık, güvenlik ve etkinlik açısından referans kaynağından klinik olarak anlamlı farklılıklara sahip olmayan lisanslı biyolojiklere (referans biyolojikler) oldukça benzer olduğu gösterilen biyolojikler olarak tanımlanmaktadır. Biyobenzerler, biyolojik kaynaklı ilaçlarla tedavisi olan hastalıklar açısından alternatif ilaçlar olarak üretilmektedir. Bu sayede kanser gibi spesifik hastalıklara yönelik tedaviler çeşitlilik kazanmaktadır. Örneğin meme kanseri için kullanılan biyobenzerler geliştirildikçe gelecekte bu hastalığın tedavilerine erişilebilirlik artacaktır ve bu gelişmeler de anti-HER2 ve anti-VEGF tedavisinin daha yaygın kullanımına olanak sağlayacaktır. Meme kanseri tedavisinde kullanılan Trastuzumab için, Avrupa patenti 2014'te, ABD patenti 2019'da sona ermiştir. Patent sürelerinin dolması bu biyobenzer ilaçların geliştirilmesini hızlandırmıştır. Bu derlemede öncelikle biyobenzerler hakkında genel bilgiler aktarılmış ve Göğüs/Meme kanseri için kullanılan biyobenzerler hakkında ayrıntılı tartışma gerçekleştirilmiştir.

Anahtar Kelimeler

Biyolojik ilaçlar, Biyobenzerler, Meme kanseri, Trastuzumab, Monoklonal Antikor(mAb)

Kaynakça

• 1. Süle, A.; Jørgensen, F.; Horák, P.; Peppard, J.; Kohl, S., Biosimilar medicines. European Journal of Hospital Pharmacy 2019, 26 (2), 117-118.
• 2. Camacho, L. H.; Frost, C. P.; Abella, E.; Morrow, P. K.; Whittaker, S., Biosimilars 101: considerations for US oncologists in clinical practice. Cancer medicine 2014, 3 (4), 889-899.
• 3. Cazap, E.; Jacobs, I.; McBride, A.; Popovian, R.; Sikora, K., Global acceptance of biosimilars: Importance of regulatory consistency, education, and trust. The oncologist 2018, 23 (10), 1188.
• 4. Bellinvia, S.; Edwards, C. J., Explaining biosimilars and how reverse engineering plays a critical role in their development. Expert Opinion on Drug Discovery 2020, 1-7.
• 5. Migliavacca Zucchetti, B.; Nicolò, E.; Curigliano, G., Biosimilars for breast cancer. Expert opinion on biological therapy 2019, 19 (10), 1015-1021.
• 6. Schiestl, M.; Ranganna, G.; Watson, K.; Jung, B.; Roth, K.; Capsius, B.; Trieb, M.; Bias, P.; Maréchal-Jamil, J., The Path Towards a Tailored Clinical Biosimilar Development. BioDrugs 2020, 34 (3), 297.
• 7. Agbogbo, F. K.; Ecker, D. M.; Farrand, A.; Han, K.; Khoury, A.; Martin, A.; McCool, J.; Rasche, U.; Rau, T. D.; Schmidt, D., Current perspectives on biosimilars. Journal of industrial microbiology & biotechnology 2019, 46 (9-10), 1297-1311.
• 8. Leung, L. K.; Mok, K.; Liu, C.; Chan, S. L., What do oncologists need to know about biosimilar products? Chinese journal of cancer 2016, 35 (1), 91.
• 9. Kadam, V.; Bagde, S.; Karpe, M.; Kadam, V., A comprehensive overview on biosimilars. Current Protein and Peptide Science 2016, 17 (8), 756-761.
• 10. Lyman, G. H., Emerging opportunities and challenges of biosimilars in oncology practice. American Society of Clinical Oncology: 2017.
• 11. Kim, Y.; Kwon, H.-Y.; Godman, B.; Moorkens, E.; Simoens, S.; Bae, S., Uptake of Biosimilar Infliximab in the UK, France, Japan, and Korea: Budget Savings or Market Expansion Across Countries? Frontiers in Pharmacology 2020, 11.
• 12. Administration, U. F. a. D. Silver Spring (MD): US Department of Health and Human Services. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapötikBiologicApplications/Biosimilars/ucm580429.htm#abbr
• 13. Bielsky, M.-C.; Cook, A.; Wallington, A.; Exley, A.; Kauser, S.; Hay, J. L.; Both, L.; Brown, D., Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial. Drug Discovery Today 2020.
• 14. Kirchhoff, C. F.; Wang, X. Z. M.; Conlon, H. D.; Anderson, S.; Ryan, A. M.; Bose, A., Biosimilars: key regulatory considerations and similarity assessment tools. Biotechnology and Bioengineering 2017, 114 (12), 2696-2705.
• 15. Sharma, A.; Kumar, N.; Kuppermann, B. D.; Bandello, F.; Loewenstein, A., Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective. British Journal of Ophthalmology 2020, 104 (1), 2-7.
• 16. Declerck, P.; Danesi, R.; Petersel, D.; Jacobs, I., The language of biosimilars: clarification, definitions, and regulatory aspects. Drugs 2017, 77 (6), 671-677.
• 17. Konstantinidou, S.; Papaspiliou, A.; Kokkotou, E., Current and future roles of biosimilars in oncology practice. Oncology Letters 2020, 19 (1), 45-51.
• 18. Li, J.; Florian, J.; Campbell, E.; Schrieber, S. J.; Bai, J. P.; Weaver, J. L.; Hyland, P. L.; Thway, T. M.; Matta, M. K.; Lankapalli, R. H., Advancing biosimilar development using pharmacodynamic biomarkers in clinical pharmacology studies. Clinical Pharmacology and Therapeutics 2020, 107 (1), 40.
• 19. Edwards, C. J.; Bellinvia, S., Biosimilars. Lupus 2020, 29 (6), 525-532.
• 20. Hung, A.; Vu, Q.; Mostovoy, L., A systematic review of US biosimilar approvals: what evidence does the FDA require and how are manufacturers responding? Journal of managed care & specialty pharmacy 2017, 23 (12), 1234-1244.
• 21. Wolff-Holz, E.; Tiitso, K.; Vleminckx, C.; Weise, M., Evolution of the EU biosimilar framework: Past and future. BioDrugs 2019, 1-14.
• 22. Cohen, H. P.; McCabe, D., The Importance of Countering Biosimilar Disparagement and Misinformation. BioDrugs 2020, 34 (4), 407-414.
• 23. Yang, J.; Yu, S.; Yang, Z.; Yan, Y.; Chen, Y.; Zeng, H.; Ma, F.; Shi, Y.; Shi, Y.; Zhang, Z., Efficacy and safety of anti-cancer biosimilars compared to reference biologics in oncology: a systematic review and meta-analysis of randomized controlled trials. BioDrugs 2019, 1-15.
• 24. Pimentel, F. F.; Morgan, G.; Tiezzi, D. G.; de Andrade, J. M., Development of new formulations of biologics: expectations, immunogenicity, and safety for subcutaneous trastuzumab. Pharmaceutical medicine 2018, 32 (5), 319-325.
• 25. Nixon, N.; Hannouf, M.; Verma, S., The evolution of biosimilars in oncology, with a focus on trastuzumab. Current Oncology 2018, 25 (Suppl 1), S171.
• 26. Patel, K. B.; Arantes Jr, L. H.; Tang, W. Y.; Fung, S., The role of biosimilars in value-based oncology care. Cancer management and research 2018, 10, 4591.
• 27. Pivot, X.; Petit, T., Can we establish a hierarchy among trastuzumab biosimilar candidates? Nature Publishing Group: 2018. 28. Geskin, L. J., Monoclonal antibodies. Dermatologic clinics 2015, 33 (4), 777-786.
• 29. Trapani, D.; Curigliano, G., How can biosimilars change the trajectory of breast cancer therapy? Taylor & Francis: 2020.
• 30. Lamb, Y. N., SB3 (Ontruzant®): a trastuzumab biosimilar. BioDrugs 2018, 32 (3), 293-296.
• 31. Lüftner, D.; Lyman, G. H.; Gonçalves, J.; Pivot, X.; Seo, M., Biologic Drug Quality Assurance to Optimize HER2+ Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3. Targeted oncology 2020, 1-9.
• 32. Blackwell, K.; Gligorov, J.; Jacobs, I.; Twelves, C., The global need for a trastuzumab biosimilar for patients with HER2-positive breast cancer. Clinical Breast Cancer 2018, 18 (2), 95-113.
• 33. Serna-Gallegos, T. R.; La-Fargue, C. J.; Tewari, K. S., The ecstacy of gold: patent expirations for trastuzumab, bevacizumab, rituximab, and cetuximab. Recent patents on biotechnology 2018, 12 (2), 101-112.
• 34. Miller, E. M.; Schwartzberg, L. S., Biosimilars for breast cancer: a review of HER2-targeted antibodies in the United States. Therapeutic Advances in Medical Oncology 2019, 11, 1758835919887044.
• 35. Tesch, M. E.; Gelmon, K. A., Targeting HER2 in Breast Cancer: Latest Developments on Treatment Sequencing and the Introduction of Biosimilars. Drugs 2020, 1-20.
• 36. Jacobs, I.; Ewesuedo, R.; Lula, S.; Zacharchuk, C., Biosimilars for the treatment of cancer: a systematic review of published evidence. BioDrugs 2017, 31 (1), 1-36.
• 37. Uifălean, A.; Ilieş, M.; Nicoară, R.; Rus, L. M.; Hegheş, S. C.; Iuga, C.-A., Concepts and challenges of biosimilars in breast cancer: the emergence of trastuzumab biosimilars. Pharmaceutics 2018, 10 (4), 168.
• 38. Stebbing, J.; Mainwaring, P. N.; Curigliano, G.; Pegram, M.; Latymer, M.; Bair, A. H.; Rugo, H. S., Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars. Journal of Clinical Oncology 2020, 38 (10), 1070.
• 39. Pivot, X.; Pegram, M. D.; Cortes, J.; Lüftner, D.; Rugo, H. S.; Lyman, G. H.; Curigliano, G.; Bondarenko, I.; Dvorkin, M.; Yoon, Y. C., Four-year follow-up of a phase III study comparing SB3 (trastuzumab biosimilar) and reference trastuzumab in HER2-positive early or locally advanced breast cancer in neoadjuvant setting. American Society of Clinical Oncology: 2020.
• 40. Pivot, X.; Bondarenko, I.; Nowecki, Z.; Dvorkin, M.; Trishkina, E.; Ahn, J.-H.; Im, S.-A.; Sarosiek, T.; Chatterjee, S.; Wojtukiewicz, M., A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: final safety, immunogenicity and survival results. European Journal of Cancer 2018, 93, 19-27.
• 41. Yun, J.; Kim, J.; Chung, J.; Hwang, S.-J.; Park, S. J., Extended Stability of Reconstituted and Diluted SB3 (Trastuzumab Biosimilar) Assessed by Physicochemical and Biological Properties. Advances in therapy 2019, 36 (7), 1700-1714.
• 42. Berg, T.; Jensen, M.-B.; Jakobsen, E. H.; Al-Rawi, S.; Kenholm, J.; Andersson, M., Neoadjuvant chemotherapy and HER2 dual blockade including biosimilar trastuzumab (SB3) for HER2-positive early breast cancer: Population based real world data from the Danish Breast Cancer Group (DBCG). The Breast 2020, 54, 242-247.
• 43. Hurvitz, S. A.; Martin, M.; Symmans, W. F.; Jung, K. H.; Huang, C.-S.; Thompson, A. M.; Harbeck, N.; Valero, V.; Stroyakovskiy, D.; Wildiers, H., Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. The Lancet Oncology 2018, 19 (1), 115-126.
• 44. Pivot, X.; Pegram, M.; Cortes, J.; Lüftner, D.; Lyman, G. H.; Curigliano, G.; Bondarenko, I.; Yoon, Y. C.; Kim, Y.; Kim, C., Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2–positive breast cancer. European Journal of Cancer 2019, 120, 1-9.
• 45. Von Minckwitz, G.; Procter, M.; De Azambuja, E.; Zardavas, D.; Benyunes, M.; Viale, G.; Suter, T.; Arahmani, A.; Rouchet, N.; Clark, E., Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. New England Journal of Medicine 2017, 377 (2), 122-131.
• 46. Del Re, M.; Del Mastro, L., Biosimilars in oncology. Focus on SB3 studies. Recenti progressi in medicina 2018, 109 (11), 531-539.
• 47. Pivot, X.; Bondarenko, I.; Petit, T.; Curtit, E., Milestones over the development of SB3, a trastuzumab biosimilar. Future Oncology 2018, 14 (27), 2795-2803.
• 48. Lee, J. H.; Paek, K.; Moon, J. H.; Ham, S.; Song, J.; Kim, S., Biological characterization of SB3, a trastuzumab biosimilar, and the influence of changes in reference product characteristics on the similarity assessment. BioDrugs 2019, 33 (4), 411-422.
• 49. Paek, K.; Kim, G.-w.; Ahn, S. Y.; Lim, J. H.; Jung, D.; Kim, S.; Lee, J. H., Assessment of the Molecular Mechanism of Action of SB3, a Trastuzumab Biosimilar. BioDrugs 2019, 33 (6), 661-671.
• 50. Minisola, S.; Cipriani, C.; Grotta, G. D.; Colangelo, L.; Occhiuto, M.; Biondi, P.; Sonato, C.; Vigna, E.; Cilli, M.; Pepe, J., Update on the safety and efficacy of teriparatide in the treatment of osteoporosis. Therapeutic Advances in Musculoskeletal Disease 2019, 11, 1759720X19877994.
• 51. Mahajan, T. D.; Mikuls, T. R., Recent advances in the treatment of rheumatoid arthritis. Current opinion in rheumatology 2018, 30 (3), 231.