Clinical Trial Development for Biosimilars

Main Article Content

Juthamas Pispingkam
Wittawat Viriyabacha

Article Details

How to Cite
1.
Pispingkam J, Viriyabacha W. Clinical Trial Development for Biosimilars. Thai Food and Drug J [Internet]. 2021 Feb. 24 [cited 2024 Nov. 23];28(1):4-9. Available from: https://he01.tci-thaijo.org/index.php/fdajournal/article/view/247813
Section
Academic Article

References

Derbyshire M. Patent expiry dates for biologicals. GaBI 2017;7(1):29-34. doi: 10.5639/gabij.2018.0701.007.

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/

Verbeeck RK. Bioequivalence, therapeutic equivalence and generic drugs. Acta Clinica Belgica 2009;64(5):379-383. doi: 10.1179/acb.2009.063.

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.

Perks B. Supporting biosimilarity and extrapolation. Generics and Biosimilars Initiative 2015;4(4):180-183. doi: 10.5639/gabij.2015.0404.041.

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

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

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

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.

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.