Health Canada Publishes Draft Biosimilar Guidance

As U.S. lawmakers discuss legislation that would enable the FDA to approve similar versions of biologic products, Health Canada has begun the process of creating a biosimilar regulatory framework.

The agency recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics” once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.

Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

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.

Comments on the draft guidance are due April 16, and Health Canada says there will be a two-day consultation in May. The draft guidance, “Information and Submission Requirements for Subsequent Entry Biologics,” along with forms for submitting comments or requesting to participate in the consultation, are available at www.hc-sc.gc.ca/dhp-mps/brgtherap/activit/consultation/seb-pbu/index_e.html.