On February 15th, ASBM submitted comments to Health Canada on its December 7th Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars), for which Health Canada has sought comment from stakeholders.   

The Guidance calls for more labeling transparency than is currently required by the FDA. For example, the SEB sponsor must include data they generate on the product’s label and must provide safety data for all indications.

The Guidance Document and information on submitting feedback may be found here.