Health Canada publishes guidance regarding follow-on biologics

ONTARIO, Canada Health Canada recently posted a draft guidance on its website containing requirements for sponsors who are seeking to submit applications for what it calls “subsequent-entry biologics” once patents for biologics begin to expire, according to published reports.

The draft provides information that would make a “subsequent-entry biologic” sponsor show that it is similar to a biologic. Each generic though would be evaluated for approval on a case-by-case basis.

A “subsequent-entry biologic” would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product.