Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars

References

• ICH. https://www.ich.org/page/mission Cited 2022 Jul 10)
   Google Scholar
• UK Government. UK joins ICH. https://www.gov.uk/government/news/mhra-joins-international-partnerships-to-set-global-standards-for-medicines-and-medical-devices-regulation–2 (Accessed 2022 Jul 10
   Google Scholar
• WHO Guidelines on Evaluation of Biosimilars. Replacement of Annex 2 of WHO Technical Report Series, No. 977 https://www.who.int/publications/m/item/guidelines-on-evaluation-of-biosimilars.WHO. (Cited 2022 Jul 10)
   Google Scholar
• Niazi S The WHO Biosimilar guidance is based on weak science. https://www.centerforbiosimilars.com/view/who-biosimilar-guidance-is-based-on-weak-science. Cited 2022 Jul 10)
   Google Scholar
• Niazi S Opinion: one step forward, half step back. https://www.centerforbiosimilars.com/view/opiniononestepforwardhalfastepbackforwhobiosimilarguidance; (Accessed on 2022 Jun 8).
   Google Scholar
• Global Biosimilar Guidelines. https://www.gabionline.net/reports/Guidelines-for-biosimilars-around-the-world (Accessed 2022 Jul 10
   Google Scholar
• CDSCO, India. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadAlertsFiles/BiosimilarGuideline2016.pdf; Accessed on 2022 Jun 8)
   Google Scholar
• FDA. Biosimilars and Interchangeable Biosimilars. [cited 2022 Aug 24]. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products
   Google Scholar
• EMA Centrally Approved Biosimilars. https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Human/ema_group_types/ema_medicine/field_ema_med_status/authorised-36/ema_medicine_types/field_ema_med_biosimilar/search_api_aggregation_ema_medicine_types/field_ema_med_biosimilar; (Cited Jun 8, 2022).
   Google Scholar
• US Congress. Title VII—improving access to innovative medical therapies subtitle a—biologics price competition and innovation. US Congress. Available online: https://www.fda.gov/media/78946/download accessed on 2022 Mar 23)
   Google Scholar
• MHRA. Biosimilar Guidance. https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products; (Accessed on 2022 Jun 8).
   Google Scholar
• Niazi SK. The Coming of Age of Biosimilars: a Personal Perspective. Biologics. 2022;2(2):107–12. [cited 2022 Aug 24].
   Google Scholar
• Niazi SK. Biosimilars: a futuristic fast-to-market advice to developers. Expert Opin Biol Ther. 2022;22(2):149–155.
   PubMed Web of Science ®Google Scholar
• Chen Y, Monnard A, Jorge Santos Da S An Inflection Point for Biosimilars, McKinsey & Co. cited 2021 Oct 12]. Available from 2021 Oct 12: https://www.mckinsey.com/industries/life-sciences/our-insights/an-inflection-point-for-biosimilars (Accessed on 2022 Jun 8).
   Google Scholar
• Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013 Sep;6(8):469–478. PMID: 24991376; PMCID: PMC4031732.
   PubMedGoogle Scholar
• Khalifeh I, et al. Adherence, Persistence, and Expenditures for High-Cost Anti-Inflammatory Drugs in Rheumatoid Arthritis: an Exploratory Study Volume 25 Issue (4). J Manag Care Spec Pharm. 2019 Apr;25(4):461–467.
   PubMed Web of Science ®Google Scholar
• Pfizer Press Release. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_goes_to_court_to_allow_competition_for_biologics_and_expand_options_for_patients (Accessed 2022 Jul 10
   Google Scholar
• Tactics to block biosimilars. https://www.biopharmadive.com/news/fda-ftc-biosimilar-competition-consumer-antitrust-laws/573745/ (Accessed 2022 Jul 10
   Google Scholar
• US Government Biosimilar Bills. https://rules.house.gov/sites/democrats.rules.house.gov/files/BILLS-116HR133SA-RCP-116-68.pdf (Accessed 2022 Jul 10
   Google Scholar
• Biosimilar Patent Litigation status. [cited 2022 Aug 14]. https://www.bigmoleculewatch.com/bpcia-patent-litigations/
   Google Scholar
• Niazi S. End Animal Testing for Biosimilar Approvals. Science. 2022;377(66020):162–163.
   PubMedGoogle Scholar
• Hajar R. Animal testing and medicine. Heart Views. 2011;12(1):42. PMID: 21731811; PMCID: PMC3123518.
   PubMedGoogle Scholar
• Norman GV. Limitations of animal studies for predicting toxicity in clinical trials: is it time to rethink our current approach? Jacc. 2019;4(7):845–854.
   Google Scholar
• Avila AM, Bebenek I, Bonzo JA, et al. An FDA/CDER perspective on nonclinical testing strategies: classical toxicology approaches and new approach methodologies (NAMs). Regul Toxicol Pharmacol. 2020;114(104662):0273–2300.
   Google Scholar
• Niazi S Analysis of FDA-licensed biosimilars–time for paradigm shift. https://www.centerforbiosimilars.com/view/analysis-of-fda-licensed-biosimilars-time-for-a-paradigm-shift Cited 2022 Jul 10)
   Google Scholar
• EMA Regulatory Science to 2025 https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf Cited 2022 Jun 8
   Google Scholar
• Moore TJ, et al. Assessment of availability, clinical testing, and US Food and Drug Administration review of biosimilar biologic products. JAMA Intern Med. 2020 Accessed on 2022 Jun 8. DOI:10.1001/jamainternmed.2020.3997
   PubMed Web of Science ®Google Scholar
• FDA. biosimilar Product Information. [cited 2022 Aug 24]. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
   Google Scholar
• Biosimilars Approved in Europe. https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe (Accessed 2022 Jul 10
   Google Scholar
• Niazi S Debate over animal toxicology studies. https://www.centerforbiosimilars.com/view/opinion-the-debate-over-animal-toxicology-studies (Accessed 2022 Jul 10
   Google Scholar
• Niazi SK, Contributor No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA https://www.centerforbiosimilars.com/view/contributor-no-animal-testing-of-biosimilars-us-congress-begins-amendment-to-bpcia. Cited 2022 Jul 10)
   Google Scholar
• Woodcock. https://www.biopharmadive.com/news/fdas-woodcock-the-clinical-trial-system-is-broken/542698/ (Accessed 2022 Jul 10
   Google Scholar
• US Congress. https://www.govinfo.gov/content/pkg/STATUTE-98/pdf/STATUTE-98-Pg1585.pdf (Accessed 2022 Jul 10
   Google Scholar
• Woodcock J, on clinical trial status. https://endpts.com/fdas-janet-woodcock-the-clinical-trials-system-is-broken/ (Accessed 2022 Jul 10
   Google Scholar
• Biosimilar EPAR Program EMA. https://www.ema.europa.eu/en/search/search/field_ema_web_categories%253Aname_field/Human/search_api_aggregation_ema_medicine_types/field_ema_med_biosimilar?search_api_views_fulltext=epar%20biosimilar (Accessed 2022 Jul 10
   Google Scholar
• FDA. Biosimilars Approval Documents. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm Cited 2022 Jul 10)
   Google Scholar
• Clinical Trial Database. https://clinicaltrials.gov/ct2/results?term=biosimilar&age_v=&gndr=&type=&rslt=With&Search=Apply (Accessed 2022 Jul 10
   Google Scholar
• Schiestl M, Ranganna G, Watson K, et al. The Path Towards a Tailored Clinical Biosimilar Development. BioDrugs. 2020 Jun;34(3):297–306.
   PubMed Web of Science ®Google Scholar
• Biosimilar Clinical Trials @PubMed. https://pubmed.ncbi.nlm.nih.gov/?term=biosimilar+clinical+trial). Cited 2022 Jul 10)
   Google Scholar
• Niazi S. Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars. Drug Des Devel Ther. 2022;16:2803–2815. PMID: 36043044; PMCID: PMC9420434.
   PubMed Web of Science ®Google Scholar
• FDA. Biosimilar Science and Research. https://www.fda.gov/drugs/biosimilars/biosimilars-science-and-research (Accessed 2022 Jul 10
   Google Scholar
• FDA. Bioequivalence and Bioavailability Testing. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.25 (Accessed 2022 Jul 10
   Google Scholar
• ICH Quality Guidelines. https://www.ich.org/page/quality-guidelines. (Accessed 2022 Jul 10.
   Google Scholar
• Niazi S Biosimilar mRNA Vaccines. https://www.centerforbiosimilars.com/view/biosimilar-mrna-vaccines-part-1-regulatory-revolution- (Accessed 2022 Jul 10
   Google Scholar
• FDA. Innovations for Biological Products. https://www.fda.gov/news-events/fda-voices/ensuring-innovation-and-competition-biologics-leads-more-timely-products-patients. (Accessed 2022 Jul 10
   Google Scholar
• FDA. Clinical Immunogenicity Concerns. Insulin https://www.fda.gov/media/133014/download Cited 2022 Jul 10)
   Google Scholar
• FDA Multiple Clinical Endpoints. https://www.fda.gov/media/162416/download Cited 2022 Jul 10)
   Google Scholar
• Garcês S, Demengeot J, Puig L, et al. Adverse Reactions to Biologics. Curr Probl Dermatol. 2018;53:37–48.
   PubMedGoogle Scholar
• Atiqi S, Hooijberg F, Loeff FC, et al. Immunogenicity of TNF-Inhibitors. Front Immunol. 2020;11:312. PMID: 32174918; PMCID: PMC7055461.
   PubMed Web of Science ®Google Scholar
• Vaisman-Mentesh A, Rosenstein S, Yavzori M, et al. Molecular Landscape of Anti-Drug Antibodies Reveals the Mechanism of the Immune Response Following Treatment With TNFα Antagonists. Front Immunol. 2019;10:2921. PMID: 31921180; PMCID: PMC6930160.
   PubMed Web of Science ®Google Scholar
• Benucci M, Grossi V, Manfredi M, et al. Laboratory monitoring of biological therapies in rheumatology: the role of immunogenicity. Ann Lab Med. 2020;40(2):101–113. PMID: 31650726; PMCID: PMC6822010.
   PubMed Web of Science ®Google Scholar
• Parikh CR, Ponnampalam JK, Seligmann G, et al. Impact of immunogenicity on clinical efficacy and toxicity profile of biologic agents used for treatment of inflammatory arthritis in children compared to adults. Ther Adv Musculoskelet Dis. 2021;13:1759720X211002685. PMID: 34188697; PMCID: PMC8212384.
   PubMed Web of Science ®Google Scholar
• EMA Immunogenicity Considerations. https://www.ema.europa.eu/en/documents/presentation/presentation-immunogenicity-therapeutic-antibodies-gertjan-wolbink_en.pdf (Accessed 2022 Jul 10
   Google Scholar
• Garcês S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis. 2013;72(12):1947–1955.
   PubMed Web of Science ®Google Scholar
• FDA. Biosimilars Labeling Requirements. https://www.fda.gov/media/96894/download Cited 2022 Jul 10)
   Google Scholar
• EudraVigilence-European database of suspected adverse drug reaction reports. https://www.adrreports.eu/en/index.html Cited 2022 Jul 10)
   Google Scholar
• FDA Adverse Events Reporting System (FAERS) https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis (Accessed 2022 Jul 10
   Google Scholar
• Word Health Organization List of SRA countries. https://www.who.int/initiatives/who-listed-authority-reg-authorities/SRAs (Accessed 2022 Jul 10
   Google Scholar