Investigation of Immunogenicity Assessment of Biosimilar Monoclonal Antibodies in the United States.
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
received:
20
02
2023
accepted:
18
08
2023
medline:
17
11
2023
pubmed:
27
8
2023
entrez:
27
8
2023
Statut:
ppublish
Résumé
Immunogenicity is critical for biologics. However, reference biologics labeling documents do not necessarily mention immunogenicity impact, rendering the development of biosimilars more challenging. We aimed to investigate the comparative assessment of immunogenicity profiles between biosimilars and their respective reference biologics in the review reports of the biosimilar monoclonal antibody applications approved by the Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA) as of March 13, 2022, covering 22 applications approved between April 5, 2016, and December 17, 2021. The maximum differences in anti-drug antibody (ADA) and neutralizing antibody (NAb) incidences between biosimilars and reference products mostly fell within ± 15% (-13.6% to 12%) and ± 20% (-17.4% to 17.1%, except extreme values of -23.4% and 66.7%), respectively. In comparison with antineoplastic agents, more immunosuppressants had ADA-positive (11/11, 100.0% vs. 8/10, 80.0%)/NAb-positive (11/11, 100.0% vs. 3/10, 30.0%) subjects, and the distribution of the aforementioned incidence differences was wider. The investigated biosimilars with available data for analysis demonstrated a high degree of consistency with their reference products in terms of the impact on pharmacokinetic parameters. No increase in immunogenicity was found in available switching studies. Most (16/22, 72.7%) biosimilars were issued post-marketing requirements that were not directly related to immunogenicity concerns. The FDA considered the totality of evidence assessing clinical consequences of immunogenicity differences, if any. Additional information on titers and subgroup analysis may be warranted to elucidate the critical attributes of immunogenicity impact and to aid in forming cost-effective strategies for biosimilar development.
Substances chimiques
Biosimilar Pharmaceuticals
0
Antibodies, Monoclonal
0
Antineoplastic Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1274-1284Subventions
Organisme : National Taiwan University (NTU) School of Pharmacy Endowment Fund
Informations de copyright
© 2023 The Authors. Clinical Pharmacology & Therapeutics © 2023 American Society for Clinical Pharmacology and Therapeutics.
Références
Trifiro, G., Marciano, I. & Ingrasciotta, Y. Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence. Expert Opin. Biol. Ther. 18, 309-315 (2018).
Boehncke, W.H. & Brembilla, N.C. Immunogenicity of biologic therapies: causes and consequences. Expert Rev. Clin. Immunol. 14, 513-523 (2018).
Urquhart, L. Top companies and drugs by sales in 2022. Nat. Rev. Drug Discov. 22, 260 (2023).
US Food and Drug Administration. Remarks from FDA commissioner Scott Gottlieb, M.D., as prepared for delivery at the brookings institution on the release of the FDA biosimilars action plan <https://www.fda.gov/news-events/press-announcements/remarks-fda-commissioner-scott-gottlieb-md-prepared-delivery-brookings-institution-release-fdas> (2018). Accessed July 15, 2022.
Grilo, A.L. & Mantalaris, A. The increasingly human and profitable monoclonal antibody market. Trends Biotechnol. 37, 9-16 (2019).
Sarpatwari, A., Barenie, R., Curfman, G., Darrow, J.J. & Kesselheim, A.S. The US biosimilar market: stunted growth and possible reforms. Clin. Pharmacol. Ther. 105, 92-100 (2019).
Gherghescu, I. & Delgado-Charro, M.B. The biosimilar landscape: an overview of regulatory approvals by the EMA and FDA. Pharmaceutics. 13, 48 (2020).
US Food and Drug Administration. Biosimilars <https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars> (2022). Accessed July 15, 2022.
Peterson, J., Budlong, H., Affeldt, T., Skiermont, K., Kyllo, G. & Heaton, A. Biosimilar products in the modern U.S. health care and regulatory landscape. J. Manag. Care Spec. Pharm. 23, 1255-1259 (2017).
Dutta, B., Huys, I., Vulto, A.G. & Simoens, S. Identifying key benefits in European off-patent biologics and biosimilar markets: it is not only about price! BioDrugs 34, 159-170 (2020).
Hung, A., Vu, Q. & Mostovoy, L. A systematic review of U.S. biosimilar approvals: what evidence does the FDA require and how are manufacturers responding? J. Manag. Care Spec. Pharm. 23, 1234-1244 (2017).
US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product> (2015). Accessed July 15, 2022.
Guinn, D., Madabushi, R., Wang, Y.M., Zineh, I. & Maxfield, K. Elucidating the impact of immunogenicity assessment postapproval: a targeted analysis of immunogenicity postmarketing requirements and commitments. Clin. Pharmacol. Ther. 109, 697-704 (2021).
US Food and Drug Administration. Guidance for industry: immunogenicity assessment for therapeutic protein products <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immunogenicity-assessment-therapeutic-protein-products> (2014). Accessed July 15, 2022.
Pineda, C., Castaneda Hernandez, G., Jacobs, I.A., Alvarez, D.F. & Carini, C. Assessing the immunogenicity of biopharmaceuticals. BioDrugs 30, 195-206 (2016).
Gulsen, A., Wedi, B. & Jappe, U. Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events. Allergo J. Int. 1-29, 97-125 (2020).
Allocati, E., Bertele, V., Gerardi, C., Garattini, S. & Banzi, R. Clinical evidence supporting the marketing authorization of biosimilars in Europe. Eur. J. Clin. Pharmacol. 76, 557-566 (2020).
Tourdot, S. et al. 10th European immunogenicity platform open symposium on immunogenicity of biopharmaceuticals. MAbs 12, 1725369 (2020).
Shankar, G. et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J. 16, 658-673 (2014).
Chirmule, N., Jawa, V. & Meibohm, B. Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy. AAPS J. 14, 296-302 (2012).
Ingrasciotta, Y., Cutroneo, P.M., Marciano, I., Giezen, T., Atzeni, F. & Trifiro, G. Safety of biologics, including biosimilars: perspectives on current status and future direction. Drug Saf. 41, 1013-1022 (2018).
Doevendans, E. & Schellekens, H. Immunogenicity of innovative and biosimilar monoclonal antibodies. Antibodies (Basel). 8, 21 (2019).
Leach, M.W., Rottman, J.B., Hock, M.B., Finco, D., Rojko, J.L. & Beyer, J.C. Immunogenicity/hypersensitivity of biologics. Toxicol. Pathol. 42, 293-300 (2014).
US Food and Drug Administration. Guidance for industry: immunogenicity testing of therapeutic protein products - developing and validating assays for anti-drug antibody detection <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immunogenicity-testing-therapeutic-protein-products-developing-and-validating-assays-anti-drug> (2019). Accessed July 15, 2022.
Declerck, P., Danesi, R., Petersel, D. & Jacobs, I. The language of biosimilars: clarification, definitions, and regulatory aspects. Drugs 77, 671-677 (2017).
Jiang, A.L., Breder, C.D. & Chang, L.C. Investigation of factors associated with immunogenicity labeling updates and characteristics of biologics license applications. Clin. Pharmacol. Ther. 110, 1381-1388 (2021).
Schreitmuller, T., Barton, B., Zharkov, A. & Bakalos, G. Comparative immunogenicity assessment of biosimilars. Future Oncol. 15, 319-329 (2019).
Moore, T.J., Mouslim, M.C., Blunt, J.L., Alexander, G.C. & Shermock, K.M. Assessment of availability, clinical testing, and US Food and Drug Administration review of biosimilar biologic products. JAMA Intern. Med. 181, 52-60 (2021).
Civoli, F. et al. Recommendations for the development and validation of immunogenicity assays in support of biosimilar programs. AAPS J. 22, 7 (2019).
US Food and Drug Administration. Guidance for industry: comparative analytical assessment and other quality-related considerations <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other-quality> (2019). Accessed July 15, 2022.
Kurki, P. Compatibility of immunogenicity guidance by the EMA and the US FDA. Bioanalysis 11, 1619-1629 (2019).
US Food and Drug Administration. Guidance for industry: clinical pharmacology data to support a demonstration of biosimilarity to a reference product <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-data-support-demonstration-biosimilarity-reference-product> (2016). Accessed July 15, 2022.
Stebbing, J. et al. Understanding the role of comparative clinical studies in the development of oncology biosimilars. J. Clin. Oncol. 38, 1070-1080 (2020).
US Food and Drug Administration. Guidance for industry: considerations in demonstrating interchangeability with a reference product <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-guidance-industry> (2019). Accessed July 15, 2022.
Kurki, P., Kang, H.N., Ekman, N., Knezevic, I., Weise, M. & Wolff-Holz, E. Regulatory evaluation of biosimilars: refinement of principles based on the scientific evidence and clinical experience. BioDrugs 36, 359-371 (2022).
Barbier, L., Ebbers, H.C., Declerck, P., Simoens, S., Vulto, A.G. & Huys, I. The efficacy, safety, and immunogenicity of switching between reference biopharmaceuticals and biosimilars: a systematic review. Clin. Pharmacol. Ther. 108, 734-755 (2020).
Lucio, S. The complexities of biosimilars and the regulatory approval process. Am. J. Manag. Care 24, S231-S236 (2018).
Gamez-Belmonte, R. et al. Biosimilars: concepts and controversies. Pharmacol. Res. 133, 251-264 (2018).
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 81, 1881-1896 (2021).
US Food and Drug Administration. Biosimilar product information <https://www.fda.gov/drugs/biosimilars/biosimilar-product-information> (2022). Accessed March 13, 2022.
European Medicines Agency. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use <https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-monoclonal-antibodies-intended-vivo-clinical-use_en.pdf> (2012). Accessed July 15, 2022.
US Food and Drug Administration. Guidance for industry: labeling for biosimilar products <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-biosimilar-products-guidance-industry> (2018). Accessed July 15, 2022.
US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs (2022) https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed 13 March 2022.
ATC/DDD Index 2022. WHO Collaborating Centre for Drug Statistics Methodology <https://www.whocc.no/atc_ddd_index/> (2022). Accessed July 15, 2022.
Song, S., Yang, L., Trepicchio, W.L. & Wyant, T. Understanding the supersensitive anti-drug antibody assay: unexpected high anti-drug antibody incidence and its clinical relevance. J. Immunol. Res. 2016, 3072586 (2016).
Wang, Y.M., Wang, J., Hon, Y.Y., Zhou, L., Fang, L. & Ahn, H.Y. Evaluating and reporting the immunogenicity impacts for biological products-a clinical pharmacology rerspective. AAPS J. 18, 395-403 (2016).
Borrega, R., Cruz, J.P., Taylor, P. & Goncalves, J. Analysis of immunogenicity data in the product information of biological drugs: a need to report immunogenicity data systematically. BioDrugs 33, 683-691 (2019).
Cohen, H.P., Blauvelt, A., Rifkin, R.M., Danese, S., Gokhale, S.B. & Woollett, G. Switching reference medicines to biosimilars: a systematic literature review of clinical outcomes. Drugs 78, 463-478 (2018).
McKinnon, R.A. et al. Biosimilarity and interchangeability: principles and evidence: a systematic review. BioDrugs 32, 27-52 (2018).