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Thank you!

Hey @ALee Not at this time based on PAAB code section 3.1.2 but something we can keep on a list to explore in the future.

Good morning, @Username Comparative data remains subject to the guidance for evidentiary basis to support comparative claims. As noted above, consideration may apply when the study can be demonstrated to be the basis for approval of the biosimilar. A study that is NOT part of the basis for approval and completed post approval, should meet the standards for high quality evidence (i.e. pre-defined statistically significance endpoints).

Good morning, @copycallosum In theory, this sounds like an acceptable activity.

Hi @Jennifer-Carroll. In your response to question 762, you mention that one of the circumstances in which PAAB will accept pooled analysis as stand-alone evidence for a therapeutic claim is when it is preplanned. However, in this scenario, you’ve indicated that data from a preplanned open-label pooled LTE is not acceptable. Could you please clarify the distinction and explain why this particular case does not meet the criteria?

Hi @Jennifer-Carroll Thank you!

Hey @mimi77 Yes. It would be considered discussion of drug therapy or content relating to drug therapy.

Hello @mimi77 During the review, you’d want to make the reviewer aware of the intended link. They will advise if it can be linked based on the content in the PAAB-exempt piece and the unbranded disease-state piece undergoing review.

Hi @support A strictly informational statement about stock such as “Product X 5mg dose now back in stock” could be considered exempt. The inclusion of the indication statement renders it no longer exempt. The inclusion of a product photo MAY render it no longer exempt. This piece should likely be submitted for an exempt opinion to assess if the product photo can be used while meeting exempt criteria.

Hey @dmauri Great question. As long as the study publication does not contain information suggesting dosing practices inconsistent with Canadian labelling, the manufacturer’s Medical/Regulatory Affairs department can confirm that the dosing in the jurisdiction where the study was conducted is the same as it is in Canada. When it comes to “SoC”, per 1.7 of the Guidance on Real-World Evidence/Data, remember that pooled comparisons are not acceptable which would render the second half of the question moot. However, if you are referring to SoC in a single-arm study (per Advisory: RWE Single-Arm Studies of Previously Treated Patients), we would look to ensure that the overwhelming majority of patients were on a product available in Canada/indicated in the same population in Canada. Regarding "SoC", please note the guidance's remarks on representing the marketplace versus exclusions by design. An opinion can be a great mechanism to get specific guidance on an individual study as it allows for assessment of the study design, therapeutic area, and indicated product(s).

Hey @JDilly11 Hard to provide comments without seeing the updated TMA copy. This question is likely better submitted as an opinion so that we can look at the update and the nature of the claims being made in current or proposed future pieces. As a general guiding principle, the assessment is made by looking at the update in combination with the APS copy to ensure it reflects the same context as the TMA. If there is something that would trigger the inclusion, then it will likely have to be added. Whether both data presentations are required will also depend on the APS copy and the finalized TMA copy.

Hey @mimi77 While we don’t provide reviews of the Forum, in general terms the claim should reflect the nature of the update. From our understanding of the description, this would be authorization in a new population (pediatrics) and not a net new indication. As such, claims should reflect “Now authorized for use in pediatric patients for x” or something similar.

Hello @msargeant Apologies for not seeing this question sooner. Per 3.1.1, post-hoc analysis are generally not considered acceptable evidence at this time. The circumstance in which post-hoc analyses would be considered acceptable is outlined in the statement that follows that copy which states “Data included in the TMA may be acceptable”. HTH.

Hey @HollyMed Yes, per the copy "In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice". Note that there may be instances where we ask for more information about US guidelines. This is extremely rare and the rationale is disclosed during the review process. If you find yourself in this rare instance, please reach out to the reviewer for clarification.

@Jennifer_CM Example 3 appears to be about the product monograph web link destination. The original question above is about linking middle level fair balance to highest level fair balance. Linking middle level fair balance to highest requires that it’s within the same tool or directly attached. A print journal ad is not the same medium as a URL link (web based) and therefore would not be acceptable.