When can we use brand names in claims when reference uses generic?
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Hi PAAB,
We're looking for clarification on when we can use brand names in claims when the reference uses the generic name.
It is our understanding based on the previous approval of APS that we can use a brand name in a place in therapy claim when the Canadian guidelines only uses the generic.
E.g.: Copy in APS says "Start with BRAND NAME X - guidelines for the treatment of disease X". This claim is supported by a guideline reference which states that "generic name X" is recommended as first-line therapy for disease X.
Can you clarify if the same applies to combination therapies? For example, BRAND NAME X has an indication in its PM, in combination with generic name Y. Could we have a header in an APS that says "BRAND NAME X + BRAND NAME Y" supported by the combined indication from BRAND NAME X's product monograph?
If the answer to the above bolded question is no, can you kindly clarify why this is different from using a brand name in an APS when the guidelines referenced uses generic?