Health Canada issues draft guidelines on follow-on biologics

03/24/2008 | FDAnews

Health Canada has issued preliminary guidance for companies seeking approval for "subsequent-entry biologics," the government's first step toward allowing the sale of follow-on versions of biotech drugs. The agency, which plans to publish more guidelines for specific biologic product classes, says existing laws authorize it to clear subsequent-entry products until legislation creates a new approval path.

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