Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective

European Medicines Agency. Omnitrope. 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/omnitrope. Accessed 19 July 2023.

US Food & Drug Administration. ZarxioTM highlights of prescribing information. 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125553s001lbl.pdf. Accessed 19 July 2023.

IQVIA. The global use of medicines 2023. 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/the-global-use-of-medicines-2023. Accessed 19 July 2023.

Association for Accessible Medicines. 2021 U.S. generic and biosimilar medicines savings report. 2021. https://accessiblemeds.org/resources/reports/2021-savings-report. Accessed 19 July 2023.

Kvien TK, Patel K, Strand V. The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems. Semin Arthritis Rheum. 2022;52:151939. https://doi.org/10.1016/j.semarthrit.2021.11.009.

Article  CAS  PubMed  Google Scholar 

US Food & Drug Administration. Guidance for industry. Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process. 2005. https://www.fda.gov/media/71489/download. Accessed 19 July 2023.

European Medicines Agency. Biosimilars in the EU: Information guide for healthcare professionals. 2019. https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Accessed 19 July 2023.

US Food & Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product. Accessed 19 July 2023.

Kurki P, Barry S, Bourges I, Tsantili P, Wolff-Holz E. Safety, immunogenicity and interchangeability of biosimilar monoclonal antibodies and fusion proteins: a regulatory perspective. Drugs. 2021;81:1881–96. https://doi.org/10.1007/s40265-021-01601-2.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Cohen HP, Blauvelt A, Rifkin RM, Danese S, Gokhale SB, Woollett G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs. 2018;78:463–78. https://doi.org/10.1007/s40265-018-0881-y.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Barbier L, Ebbers HC, Declerck P, Simoens S, Vulto AG, Huys I. The efficacy, safety, and immunogenicity of switching between reference biopharmaceuticals and biosimilars: a systematic review. Clin Pharmacol Ther. 2020;108:734–55. https://doi.org/10.1002/cpt.1836.

Article  PubMed  PubMed Central  Google Scholar 

US Food & Drug Administration. Guidance for industry. Considerations in demonstrating interchangeability with a reference product. 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-guidance-industry. Accessed 19 July 2023.

Park JP, Jung B, Park HK, Shin D, Jung JA, Ghil J, et al. Interchangeability for biologics is a legal distinction in the USA, not a clinical one. BioDrugs. 2022;36:431–6. https://doi.org/10.1007/s40259-022-00538-6.

Article  PubMed  PubMed Central  Google Scholar 

Schiestl M, Ranganna G, Watson K, Jung B, Roth K, Capsius B, et al. The path towards a tailored clinical biosimilar development. BioDrugs. 2020;34:297–306. https://doi.org/10.1007/s40259-020-00422-1.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Webster CJ, George KL, Woollett GR. Comparability of biologics: global principles, evidentiary consistency and unrealized reliance. BioDrugs. 2021;35:379–87. https://doi.org/10.1007/s40259-021-00488-5.

Article  PubMed  PubMed Central  Google Scholar 

Webster CJ, Wong AC, Woollett GR. An efficient development paradigm for biosimilars. BioDrugs. 2019;33:603–11. https://doi.org/10.1007/s40259-019-00371-4.

Article  PubMed  PubMed Central  Google Scholar 

Klein K, Gencoglu M, Heisterberg J, Acha V, Stolk P. The global landscape of manufacturers of follow-on biologics: an overview of five major biosimilar markets and 15 countries. BioDrugs. 2023;37:235–45. https://doi.org/10.1007/s40259-022-00568-0.

Article  PubMed  Google Scholar 

McKinsey & Company. Three imperatives for R&D in biosimilars. 2022. https://www.mckinsey.com/industries/life-sciences/our-insights/three-imperatives-for-r-and-d-in-biosimilars. Accessed 19 July 2023.

Moore TJ, Mouslim MC, Blunt JL, Alexander GC, Shermock KM. Assessment of availability, clinical testing, and US food and drug administration review of biosimilar biologic products. JAMA Intern Med. 2021;181:52–60. https://doi.org/10.1001/jamainternmed.2020.3997.

Article  CAS  PubMed  Google Scholar 

European Commission. Biosimilar medicines—multistakeholder event. 2022. https://health.ec.europa.eu/events/biosimilar-medicines-multistakeholder-event-2022-12-13_en. Accessed 19 July 2023.

IQVIA. Biosimilars in the United States 2023–2027. 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027. Accessed 19 July 2023.

Bielsky M, Cook A, Wallington A, Exley A, Kauser S, Hay JL, et al. Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial. Drug Discov Today. 2020;25:1910–8. https://doi.org/10.1016/j.drudis.2020.09.006.

Article  CAS  Google Scholar 

Guillen E, Ekman N, Barry S, Weise M, Wolff-Holz E. A data driven approach to support tailored clinical programs for biosimilar monoclonal antibodies. Clin Pharmacol Ther. 2023;113:108–23. https://doi.org/10.1002/cpt.2785.

Article  CAS  PubMed  Google Scholar 

US Food & Drug Administration. BsUFA III regulatory research pilot program: research roadmap. 2023. https://www.fda.gov/media/164751/download. Accessed 19 July 2023.

Bloomfield D, D’Andrea E, Nagar S, Kesselheim A. Characteristics of clinical trials evaluating biosimilars in the treatment of cancer: a systematic review and meta-analysis. JAMA Oncol. 2022;8:537–45. https://doi.org/10.1001/jamaoncol.2021.7230.

Article  PubMed  PubMed Central  Google Scholar 

Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS. FDA and EMA biosimilar approvals. J Gen Intern Med. 2020;35:1908–10. https://doi.org/10.1007/s11606-019-05408-6.

Article  PubMed  Google Scholar 

US Food & Drug Administration. Biosimilar multi-disciplinary evaluation and review (BMER) BLA 761111 (Nyvepria). 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761111Orig1s000MultidisciplineR.pdf. Accessed 19 July 2023.

US Food & Drug Administration. Biosimilar multi-disciplinary evaluation and review (BMER) BLA 761173 (Stimufend). 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761173Orig1s000MultidisciplineR.pdf. Accessed 19 July 2023.

US Food & Drug Administration. Biosimilar multi-disciplinary evaluation and review (BMER) BLA 761084 (Fylnetra). 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761084Orig1s000MultidisciplineR.pdf. Accessed 19 July 2023.

US Food & Drug Administration. Biosimilar clinical review BLA 761082 (Releuko). 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761082Orig1s000MedR.pdf. Accessed 19 July 2023.

Wolff-Holz E, Tiitso K, Vleminckx C, Weise M. Evolution of the EU biosimilar framework: past and future. BioDrugs. 2019;33:621–34. https://doi.org/10.1007/s40259-019-00377-y.

Article  PubMed  PubMed Central  Google Scholar 

Medicines & Healthcare products Regulatory Agency. Guidance on the licensing of biosimilar products. 2022. https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products. Accessed 19 July 2023.

World Health Organization. Guidelines on evaluation of biosimilars. Replacement of annex 2 of WHO technical report series, no. 977. 2022. https://cdn.who.int/media/docs/default-source/biologicals/bs-documents-(ecbs)/annex-3---who-guidelines-on-evaluation-of-biosimilars_22-apr-2022.pdf?sfvrsn=e127cbf4_1&download=true. Accessed 19 July 2023.

Duke-Margolis Center for Health Policy. Public workshop. Pharmacodynamic biomarkers for biosimilar development and approval. 2021. https://healthpolicy.duke.edu/sites/default/files/2021-09/Presentation%20Slides_PD%20Biomarkers%20for%20Biosimilar%20Development%20and%20Approval_2021-09-27_0.pdf. Accessed 19 July 2023.

van der Graaf PH, Giacomini K, Cascorbi I, Chung C, Holstein S, Joshi A, et al. Innovations in biosimilars. Clin Pharmacol Ther. 2023;113:1–195. https://doi.org/10.1002/cpt.2653.

Article  Google Scholar 

Woollett GR, Park JP, Han J, Jung B. The role of PD biomarkers in biosimilar development—to get the right answer one must first ask the right question. Clin Pharmacol Ther. 2023;113:50–4. https://doi.org/10.1002/cpt.2753.

Article  CAS  PubMed  Google Scholar 

Jawa V, Terry F, Gokemeijer J, Mitra-Kaushik S, Roberts BJ, Tourdot S, et al. T-cell dependent immunogenicity of protein therapeutics pre-clinical assessment and mitigation-updated consensus and review 2020. Front Immunol. 2020;11:1301. https://doi.org/10.3389/fimmu.2020.01301.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ben-Horin S, Yavzori M, Benhar I, Fudim E, Picard O, Ungar B, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2016;65:1132–8. https://doi.org/10.1136/gutjnl-2015-309290.

Article  CAS  PubMed  Google Scholar 

Ruiz-Argüello MB, Maguregui A, Ruiz del Agua A, Pascual-Salcedo D, Martínez-Feito A, Jurado T, et al. Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars. Ann Rheum Dis. 2016;75:1693–6. https://doi.org/10.1136/annrheumdis-2015-208684.

Article  CAS  PubMed  Google Scholar 

Nupur N, Joshi S, Gulliarme D, Rathore AS. Analytical similarity assessment of biosimilars: Global regulatory landscape, recent studies and major advancements in orthogonal platforms. Front Bioeng Biotech. 2022;10:832059. https://doi.org/10.3389/fbioe.2022.832059.

Article  Google Scholar 

Vulto AG, Jaquez OA. The process defines the product: what really matters in biosimilar design and production? Rheumatology. 2017;56:iv14–29. https://doi.org/10.1093/rheumatology/kex278.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lamanna WC, Mayer RE, Rupprechter A, Fuchs M, Higel F, Fritsch C, et al. The structure-function relationship of disulfide bonds in etanercept. Sci Rep. 2017;7:3951. https://doi.org/10.1038/s41598-017-04320-5.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, et al. Maintaining consistent quality and clinical performance of biopharmaceuticals. Expert Opin Biol Ther. 2018;18:369–79. https://doi.org/10.1080/14712598.2018.1421169.

Article  CAS  PubMed  Google Scholar 

Kurki P, van Aerts L, Wolff-Holz E, Giezen T, Skibeli V, Weise M. Interchangeability of biosimilars: a European perspective. BioDrugs. 2017;31:83–91. https://doi.org/10.1007/s40259-017-0210-0.

Article  CAS  PubMed  Google Scholar 

Medicines for Europe. Billions more euros to re-invest in better healthcare thanks to biosimilar medicines. 2022. https://www.medicinesforeurope.com/wp-content/uploads/2022/12/20221213-Press-Release-Bios-stakeholder-workshop.pdf#:~:text=Biosimilar%20medicines%20have%20now%20generated%20over%2030%20billion,4.5%20billion%20patient%20treatment%20days%20of%20positive%20experience. Accessed 19 July 2023.

Biosimilars Council. Biosimilars are a prescription for better health. 2022. https://biosimilarscouncil.org/. Accessed 19 July 2023.

European Medicines Agency. EudraVigilance. 2023. https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance. Accessed 19 July 2023.

US Food & Drug Administration. FDA's Sentinel initiative. 2023. https://www.fda.gov/safety/fdas-sentinel-initiative. Accessed 19 July 2023.

Xue X, Truong B, Qian J. Adverse event reporting of marketed biosimilar and biological monoclonal antibody cancer treatments in the United States. Expert Opin Biol Ther. 2023. https://doi.org/10.1080/14712598.2023.2189007.

Article  PubMed  Google Scholar 

Allocati E, Godman B, Gobbi M, Garattini S, Banzi R. Switching among biosimilars: a review of clinical evidence. Front Pharmacol. 2022;13:917814. https://doi.org/10.3389/fphar.2022.917814.

Article  PubMed  PubMed Central  Google Scholar 

Cohen HP, Hachaichi S, Bodenmueller W, Kvien TK, Danese S, Blauvelt A. Switching from one biosimilar to another biosimilar of the same reference biologic: a systematic review of studies. BioDrugs. 2022;36:625–37. https://doi.org/10.1007/s40259-022-00546-6.

Article  PubMed  PubMed Central 

留言 (0)

沒有登入
gif