Canada joins EU on the biosimilars train
This article was originally published in The Gold Sheet
Executive Summary
Health Canada has issued a "Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs). The document guides sponsors on information and regulatory requirements for subsequent entry biologic products in Canada. The concept of a SEB applies to all biologic drug submissions in which the sponsor would, based on demonstrated similarity to a reference biologic product, rely in part on publicly available information from a previously approved biologic drug in order to present a reduced clinical package as part of the submission. The EU has allowed approval of biosimilar products since 2005. Biosimilar legislation is currently pending in the U.S. and is being held up by legislators' concerns on extended data exclusivity for brand companies and coming to terms with what should constitute a biosimilar drug