Clinical Trial Development for Biosimilars
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Published:
Feb 24, 2021
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Pispingkam J, Viriyabacha W. Clinical Trial Development for Biosimilars. TFDJ [Internet]. 2021 Feb. 24 [cited 2024 Apr. 24];28(1):4-9. Available from: https://he01.tci-thaijo.org/index.php/fdajournal/article/view/247813
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References
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2. Sanjeev KG, Chaudhari PS, Rajalaxmi N. Opportunities and challenges in biosimilar development [internet]. Burlington MA: BioProcess International; 2017 [cited 2019 May 6] .Avialable from: https://bioprocessintl.com/manufacturing/biosimilars/opportunities-challenges-biosimilar-development/
3. Verbeeck RK. Bioequivalence, therapeutic equivalence and generic drugs. Acta Clinica Belgica 2009;64(5):379-383. doi: 10.1179/acb.2009.063.
4. Dranitsaris G, Dorward K, Hatzimichael E, Amir E. Clinical trial design in biosimilar drug development. Investigational New Drugs 2012;31(2):479-487. doi: 10.1007/s10637-012-9899-2.
5. Perks B. Supporting biosimilarity and extrapolation. Generics and Biosimilars Initiative 2015;4(4):180-183. doi: 10.5639/gabij.2015.0404.041.
6. U.S. Food and Drug Administration. Biosimilar development, review, and approval: Can a biosimilar be approved for an indication that is approved for the reference product even if the biosimilar is not directly studied in that indication? [Internet]. U.S FDA; 2015. [cited 2019 May 6]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval#indication
7. U.S. Food and Drug Administration. Guidance document: Scientific considerations in demonstrating biosimilarity to a reference product [Internet]. U.S FDA; 2015. [cited 2019 May 6]. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
8. World Health Organization. Guidelines on evaluation of similar biotherapeutic product (SBPs) [Internet]. WHO; 2009. [cited 2019 May 6].Available from: https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
9. Tesser JR, Furst DE, Jacobs I. Biosimilars and the extrapolation of indications for inflammatory conditions. Biologics: targets & therapy 2017;11:5–11. doi: 10.2147/BTT.S124476.
10. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood 2014;124(22):3191-3196. doi: 10.1182/blood-2014-06-583617.
2. Sanjeev KG, Chaudhari PS, Rajalaxmi N. Opportunities and challenges in biosimilar development [internet]. Burlington MA: BioProcess International; 2017 [cited 2019 May 6] .Avialable from: https://bioprocessintl.com/manufacturing/biosimilars/opportunities-challenges-biosimilar-development/
3. Verbeeck RK. Bioequivalence, therapeutic equivalence and generic drugs. Acta Clinica Belgica 2009;64(5):379-383. doi: 10.1179/acb.2009.063.
4. Dranitsaris G, Dorward K, Hatzimichael E, Amir E. Clinical trial design in biosimilar drug development. Investigational New Drugs 2012;31(2):479-487. doi: 10.1007/s10637-012-9899-2.
5. Perks B. Supporting biosimilarity and extrapolation. Generics and Biosimilars Initiative 2015;4(4):180-183. doi: 10.5639/gabij.2015.0404.041.
6. U.S. Food and Drug Administration. Biosimilar development, review, and approval: Can a biosimilar be approved for an indication that is approved for the reference product even if the biosimilar is not directly studied in that indication? [Internet]. U.S FDA; 2015. [cited 2019 May 6]. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval#indication
7. U.S. Food and Drug Administration. Guidance document: Scientific considerations in demonstrating biosimilarity to a reference product [Internet]. U.S FDA; 2015. [cited 2019 May 6]. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
8. World Health Organization. Guidelines on evaluation of similar biotherapeutic product (SBPs) [Internet]. WHO; 2009. [cited 2019 May 6].Available from: https://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
9. Tesser JR, Furst DE, Jacobs I. Biosimilars and the extrapolation of indications for inflammatory conditions. Biologics: targets & therapy 2017;11:5–11. doi: 10.2147/BTT.S124476.
10. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood 2014;124(22):3191-3196. doi: 10.1182/blood-2014-06-583617.