References
- US Food and Drug Administration (FDA). Patient materials 2020. [cited 2020 Oct 7]. Available from: https://www.fda.gov/drugs/biosimilars/patient-materials
- Morrow T, Felcone LH. Defining the difference: what makes biologics unique. Biotechnol Healthc. 2004;1(4):24–29.
- European Medicines Agency. Guideline on similar biological medicinal products. London: EMA; 2014 [cited 2014 Oct 23]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf
- US Food and Drug Administration (FDA). Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. Silver Spring (MD): FDA; 2015. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
- European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). 2014 [cited 2014 May 22]. Available from: https://www.ema.europa.eu/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf
- US Food and Drug Administration (FDA). Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product; guidance for industry 2015.[cited 2020 Feb27]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-considerations-demonstrating-biosimilarity-therapeutic-protein-product-reference-product
- US Food and Drug Administration (FDA). Clinical pharmacology data to support a demonstration of biosimilarity to a reference product 2016. [cited 2020 May 6]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-data-support-demonstration-biosimilarity-reference-product
- US Food and Drug Administration (FDA). Development of Therapeutic protein biosimilars: Comparative analytical assessment and other quality-related considerations 2019. [cited 2018 Mar 2]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-therapeutic-protein-biosimilars-comparative-analytical-assessment-and-other-quality
- Stebbing J, Mainwaring PN, Curigliano G, et al. Understanding the role of comparative clinical studies in the development of oncology biosimilars. J Clin Oncol. 2020;38(10):1070–1080. doi: 10.1200/JCO.19.02953
- US Food and Drug Administration (FDA). Biosimilar development, review, and approval. 2017 [cited 2017 Oct 20]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval
- European Medicines Agency. Biosimilar medicines: marketing authorisation. Available from: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/biosimilar-medicines-marketing-authorisation
- Chanchlani N, Mortier K, Williams LJ, et al. Use of infliximab biosimilar versus originator in a pediatric United Kingdom inflammatory bowel disease induction cohort. J Pediatr Gastroenterol Nutr. 2018;67(4):513–519. doi: 10.1097/MPG.0000000000002011
- Gulacsi L, Brodszky V, Baji P, et al. The rituximab biosimilar CT-P10 in rheumatology and cancer: a budget impact analysis in 28 European countries. Adv Ther. 2017;34(5):1128–1144. doi: 10.1007/s12325-017-0522-y
- Jha A, Upton A, Dunlop WC, et al. The Budget impact of biosimilar infliximab (Remsima®) for the treatment of autoimmune diseases in five European countries. Adv Ther. 2015;32(8):742–756. doi: 10.1007/s12325-015-0233-1
- Kim J, Ha D, Song I, et al. Estimation of cost savings between 2011 and 2014 attributed to infliximab biosimilar in the South Korean healthcare market: real-world evidence using a nationwide database. Int J Rheum Dis. 2018;21(6):1227–1236. doi: 10.1111/1756-185X.13295
- Tee M, Tee CA. Pms19 - a budget impact analysis of introducing a forced treatment pathway using the lowest priced anti-tumor necrosis factor agent for rheumatoid arthritis and ankylosing spondylitis in the philippines. Value Health. 2018;21:S290–S291. doi: 10.1016/j.jval.2018.09.1733
- ICH. ICH Guideline. The common technical document for the registration of pharmaceuticals for human use: Quality – M4Q(R1). 2002 [cited 2002 Sep 12]. Available from: https://database.ich.org/sites/default/files/M4Q_R1_Guideline.pdf
- Arato T. Japanese regulation of biosimilar products: past experience and current challenges. Br J Clin Pharmacol. 2016;82(1):30–40. doi: 10.1111/bcp.12931
- Ingram B, Lumsden RS, Radosavljevic A, et al. Analysis of the regulatory science applied to a single portfolio of eight biosimilar product approvals by four key regulatory authorities. Pharmaceuticals (Basel). 2021;14(4):306. doi: 10.3390/ph14040306
- Cilia M, Ruiz S, Richardson P, et al. Quality issues identified during the evaluation of biosimilars by the European Medicines Agency’s committee for medicinal products for human use. AAPS Pharm Sci Tech. 2018;19(2):489–511. doi: 10.1208/s12249-017-0892-0