Patient materials for orginator therapy and biosimilar
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We're creating patient materials about an originator therapy and its biosimilar. If I refer to the therapy throughout the APS by its non-proprietary name, could we also include the different brand names in parentheses at first mention of the product? Or can we only include the non-proprietary name throughout the piece?
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We're creating patient materials about an originator therapy and its biosimilar. If I refer to the therapy throughout the APS by its non-proprietary name, could we also include the different brand names in parentheses at first mention of the product? Or can we only include the non-proprietary name throughout the piece?
Hello @jennifer_bco
Patient pieces should be restricted to information about the product the patient has been prescribed. There should be no mention of competitors. Sponsors should restrict discussions to those presented in part III of the TMA.
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Hello @jennifer_bco
Patient pieces should be restricted to information about the product the patient has been prescribed. There should be no mention of competitors. Sponsors should restrict discussions to those presented in part III of the TMA.
@jennifer-carroll Would the same apply if both therapies are from the same company? Could we reference both part III sections of the TMAs if the wording was the same?
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@jennifer-carroll Would the same apply if both therapies are from the same company? Could we reference both part III sections of the TMAs if the wording was the same?
Hey @jennifer_bco
The same applies if both therapies are from the same company.
If the sponsor makes the originator, patients on the originator should not receive patient information which speaks to the biosimilar. Patients who are on the biosimilar can receive patient information which is limited to mention of the reference drug product in the exact same context/content as mentioned in part III of the biosimilar TMA.
