A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy.

da Silva Machado, FL; Cañás, M; Urtasun, MA; Marín, GH; Albuquerque, FC; Pont, L; Convertino, I; Bonaso, M; Tuccori, M; Kirchmayer, U; Lopes, LC

A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy.

da Silva Machado, FL Cañás, M Urtasun, MA Marín, GH Albuquerque, FC Pont, L

Convertino, I Bonaso, M Tuccori, M Kirchmayer, U Lopes, LC

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Publisher:: SPRINGER HEIDELBERG
Publication Type:: Journal Article
Citation:: Ther Innov Regul Sci, 2024, 58, (3), pp. 549-556
Issue Date:: 2024-05

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Field	Value	Language
dc.contributor.author	da Silva Machado, FL
dc.contributor.author	Cañás, M
dc.contributor.author	Urtasun, MA
dc.contributor.author	Marín, GH
dc.contributor.author	Albuquerque, FC
dc.contributor.author	Pont, L https://orcid.org/0000-0002-8545-716X
dc.contributor.author	Convertino, I
dc.contributor.author	Bonaso, M
dc.contributor.author	Tuccori, M
dc.contributor.author	Kirchmayer, U
dc.contributor.author	Lopes, LC
dc.date.accessioned	2024-10-08T22:19:08Z
dc.date.available	2024-01-19
dc.date.available	2024-10-08T22:19:08Z
dc.date.issued	2024-05
dc.identifier.citation	Ther Innov Regul Sci, 2024, 58, (3), pp. 549-556
dc.identifier.issn	2168-4790
dc.identifier.issn	2168-4804
dc.identifier.uri	http://hdl.handle.net/10453/181248
dc.description.abstract	BACKGROUND: Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments. OBJECTIVE: This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries. METHOD: This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage. RESULTS: Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2). CONCLUSION: The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.
dc.format	Print-Electronic
dc.language	eng
dc.publisher	SPRINGER HEIDELBERG
dc.relation.ispartof	Ther Innov Regul Sci
dc.relation.isbasedon	10.1007/s43441-024-00623-8
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject.mesh	Biosimilar Pharmaceuticals
dc.subject.mesh	Italy
dc.subject.mesh	Argentina
dc.subject.mesh	Brazil
dc.subject.mesh	Australia
dc.subject.mesh	Humans
dc.subject.mesh	Drug Costs
dc.subject.mesh	Costs and Cost Analysis
dc.subject.mesh	Humans
dc.subject.mesh	Costs and Cost Analysis
dc.subject.mesh	Drug Costs
dc.subject.mesh	Argentina
dc.subject.mesh	Brazil
dc.subject.mesh	Australia
dc.subject.mesh	Italy
dc.subject.mesh	Biosimilar Pharmaceuticals
dc.subject.mesh	Biosimilar Pharmaceuticals
dc.subject.mesh	Italy
dc.subject.mesh	Argentina
dc.subject.mesh	Brazil
dc.subject.mesh	Australia
dc.subject.mesh	Humans
dc.subject.mesh	Drug Costs
dc.subject.mesh	Costs and Cost Analysis
dc.title	A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy.
dc.type	Journal Article
utslib.citation.volume	58
utslib.location.activity	Switzerland
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/UTS Groups
pubs.organisational-group	University of Technology Sydney/UTS Groups/UTS Ageing Research Collaborative (UARC)
utslib.copyright.status	closed_access	*
dc.date.updated	2024-10-08T22:19:06Z
pubs.issue	3
pubs.publication-status	Published
pubs.volume	58
utslib.citation.issue	3

Abstract:

BACKGROUND: Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments. OBJECTIVE: This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries. METHOD: This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage. RESULTS: Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2). CONCLUSION: The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.

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http://hdl.handle.net/10453/181248