Comparative Biosimilar Data
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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!
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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!
Good Morning @stet
With the exception of opioids and NOC/c products, study data presentations in APS are not generally required to emanate from the product monograph. Consequently, we would not expect the described template change to have widespread implications across current or future biosimilars. While the exclusion of entire comparative studies from the PM could theoretically impact isolated instances in which the study data would be unacceptable due to evidentiary quality, the manufacturer may overcome such a challenge by providing evidence that the study was the basis for approval of the biosimilar.
Please note that this should not be interpreted as meaning that all data from those studies would necessarily be accepted. For example, data presentations may not conflict with the TMA. To highlight just one specific example, if the monograph states that the efficacy was similar to the reference product, data showcasing statistical superiority of the biosimilar would contradict the TMA and would therefore be disallowed per section 3.1 of the PAAB Code and section 9.1 of the Food and Drugs Act.
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Good Morning @stet
With the exception of opioids and NOC/c products, study data presentations in APS are not generally required to emanate from the product monograph. Consequently, we would not expect the described template change to have widespread implications across current or future biosimilars. While the exclusion of entire comparative studies from the PM could theoretically impact isolated instances in which the study data would be unacceptable due to evidentiary quality, the manufacturer may overcome such a challenge by providing evidence that the study was the basis for approval of the biosimilar.
Please note that this should not be interpreted as meaning that all data from those studies would necessarily be accepted. For example, data presentations may not conflict with the TMA. To highlight just one specific example, if the monograph states that the efficacy was similar to the reference product, data showcasing statistical superiority of the biosimilar would contradict the TMA and would therefore be disallowed per section 3.1 of the PAAB Code and section 9.1 of the Food and Drugs Act.
@jennifer-carroll Wonderful, thank you.
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Hello @Jennifer-Carroll, would this mean that safety data from a comparative clinical trial would be permitted in a promotional piece (knowing that there is typically no p-value for safety endpoint), or would comparative trials still be subjected to the "Guidance on secondary endpoints" as other trials outside the PM? And, would it change if the study was NOT the basis for the approval, but was carried out subsequently? Thank you!
