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@jennifer-carroll Wonderful, thank you.

Based on this policy directive from Health Canada, any clinical comparison study data with the reference biologic must now be removed from the Product Monographs of biosimilars.

Would the PAAB ever still consider that data in a branded APS, or is the implication that it should also be removed from advertising in all cases?

Thanks!

@jennifer-carroll Thank you!

I've noticed that several of the COVID-19 vaccines have a black box warning on the cover of the Product Monograph that states that the product has been authorized with Terms & Conditions, and that patients should be advised of the nature of the authorization.

But they aren't actually NOC/c, listed on the NOC database as without conditions.

How would the PAAB review these vaccines -- are they required to disclose their Terms & Conditions approval with a black box as with NOC/c products?

If a product has been recently approved with a novel mechanism of action that targets (for example) a unique signalling pathway, is it acceptable to create an unbranded HCP-directed mechanism of disease APS that focuses on that pathway?

Or would that inherently brand the APS as there is only one treatment available targeting that mechanism of disease?

@jennifer-carroll Thanks, Jennifer. When it comes to those subsequent rounds of feedback when new changes would need to be highlighted, would we retain the highlighting of the previously-approved content as well? Or would it be okay in that circumstance to remove them as they've been seen and accepted?

We're confused about the reasoning behind the change to highlighting requirements when there is verbatim content picked up from previous efiles.

Highlighting what is old rather than what is new is a very strange process, when in every other submission the highlighted copy is intended to show PAAB what has changed from the previous version.

Are these new guidelines subject to change based on feedback, or are they set in stone?