The regulatory and market access landscape for biosimilars is constantly evolving. For a company seeking to develop a biosimilar for multiple markets, keeping track of the similarities and differences in different countries can be a significant challenge. The Access & Reimbursement Overview allows rapid assessment of key market access parameters across the United States, EU5, Japan, Australia, Canada, and key emerging markets.<\/p>\n
Questions answered<\/p>\n
Does a dedicated biosimilar pathway exist in the country of interest?
\nWhat types of biological products fall within the scope of biosimilar guidance?
\nWhat are the regulatory considerations with regard to reference-product selection?
\nIs automatic pharmacy-level substitution permitted?
\nWhat pricing mechanisms exist for biosimilars and their reference products?
\nIs the local government actively driving biosimilar uptake?
\nKey markets covered<\/p>\n
France, Germany, Italy, Spain, United Kingdom, United States, Japan, Australia, Brazil, Canada, China, India, Mexico, Russia, and South Korea.<\/p>\n
Key companies mentioned<\/p>\n
Amgen
\nBoehringer Ingelheim
\nCelltrion
\nEli Lilly
\nHospira
\nMerck & Co.
\nMylan
\nPfizer
\nRoche
\nSamsung Bioepis
\nSandoz
\nKey drugs mentioned<\/p>\n
Avastin
\nBasaglar
\nBenepali
\nBinocrit
\nBrenzys
\nEnbrel
\nHerceptin
\nHumira
\nInflectra
\nNeulasta
\nNivestim
\nRemicade
\nRenflexis
\nRemsima
\nRituxan\/MabThera
\nTruxima
\nZarzio\/Zarxio<\/p>\n","protected":false},"template":"","class_list":["post-390412","report","type-report","status-publish","hentry","report-gateway-biopharma","biopharma-product-biosimilars","biopharma-date-931"],"acf":[],"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report\/390412","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/report"}],"version-history":[{"count":2,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report\/390412\/revisions"}],"predecessor-version":[{"id":576634,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/report\/390412\/revisions\/576634"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=390412"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}