Biosimilar development1,3 Demonstrate no clinically meaningful differences in safety and effectiveness in one or more appropriate conditions of use for which the reference product is licensed.
Demonstrate no clinically meaningful differences in safety and effectiveness in one or more appropriate conditions of use for which the reference product is licensed.
References: 1. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed October 29, 2019. 2. Conner J, Wuchterl D, Lopez M, et al. The biomanufacturing of biotechnology products. In: Shimasaki C, ed. Biotechnology Entrepreneurship: Starting, Managing, and Leading Biotech Companies. Waltham, MA: Academic Press; 2014:351-385. 3. Blauvelt A, Cohen AD, Puig L, Vender R, van der Walt J, Wu JJ. Biosimilars for psoriasis: preclinical analytical assessment to determine similarity. Br J Dermatol. 2016;174:282-286. 4. Kresse GB. Biosimilars—science, status and strategic perspective. Eur J Pharm Biopharm. 2009;72:479-486. 5. European Medicines Agency. Guideline on similar biological medicinal products. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/ WC500176768.pdf. Accessed October 29, 2019. 6. US Federal Trade Commission. Emerging health care issues: follow-on biologic drug competition. www.ftc.gov/reports/emerging-healthcare-issues-follow-biologic-drug-competition-federal-trade-commission-report/. Accessed October 29, 2019. 7. Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015;44:S2-S8. 8. European Medicines Agency. Biosimilars in the EU: information guide for healthcare professionals. www.ema.europa.edu/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Accessed October 29, 2019.