Update: The comparison chart was last updated September, 2020.
As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and Camilla Balleny of Carpmaels & Ransford to prepare the chart below comparing relevant considerations for biosimilars in Canada, the US, and Europe, including regulatory pathways, data protection and patent linkage.
Related Publications & Articles
-
Ontario proposes legislation to regulate preferred provider networks
Following two public consultations with stakeholders, the Government of Ontario (Ministry of Finance) is moving forward with legislation to regulate preferred provider networks (PPNs).Read More -
Canada’s Drug Agency releases new resource and data on drug approval and reimbursement pathway
Canada’s Drug Agency (CDA-AMC) published data on Canada’s drug system as part of the Data Systems and Analytics program.Read More -
Health Canada and U.S. FDA agree to establish information sharing program for generic drug submission reviews
Health Canada and the U.S. Food and Drug Administration (FDA) have created a program to support the establishment of a Request for Information Sharing (RIS) program, which will enhance the exchange of...Read More
