Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Use of Biosimilar-Specific Stability Data
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Hey @cscholes
Claims within advertising for biosimilars must meet the same rigors of the Code as other products. Studies from outside of the TMA must be consistent with the TMA. They must also meet PAAB Code requirements for evidence e.g. well-designed, published, peer-reviewed, statistically supported claims based on predefined endpoints, on label, etc.). If you’re not certain if a specific study meets those requirements, we encourage you to submit for an opinion review. Please be specific about how you’d like to use the study in order to receive the most comprehensive opinion.
