Forum

Jennifer Carroll

Process flow is a business decision. PAAB has adjusted its requirements for Medical/Regulatory sign-off to respect this fact.

What's changing?
PAAB will no longer require med/reg review to occur prior to initial PAAB submission. Upon submitting, if you have opted not to complete Medical/Regulatory review prior to PAAB review, please click "Not Yet" on the submission form. If Medical/Regulatory review was completed, you will continue to have the option to confirm this and provide the Manufacturer Medical/Regulatory contact.

Click here to more about why, new form requirements, and what this means for the review process.

Question? Post below and we'll get back to you.
Thanks
PAAB

Jennifer Carroll

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.

Jennifer Carroll

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).

Jennifer Carroll

Good morning, @copycallosum

In theory, this sounds like an acceptable activity.

Jennifer Carroll

Hey @adelaidebaker

Yes.
Experience claims should not be positioned in a manner which suggests significance to the listing or vise versa. It cannot be stated or inferred that the experience is linked to coverage or that coverage is due to the experience.
Patient information should be informational and not promotional. The copy “Now covered on ODB” would be considered promotional. For acceptable communications around formulary coverage, see Guidance on branded patient information section 1.3 Formulary Statements.

Jennifer Carroll

Hey @mimi77

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

Jennifer Carroll

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.

Jennifer Carroll

Hey @ALee

Let’s ensure we’re talking about the same thing when we say “abstract”. When we refer to “abstracts” in the response above, we’re speaking to acceptable abstracts (the published abstract from a published peer-reviewed study that meets the standards of the Code).

This is in contrast to ‘abstracts’ per Code section 3.1.2ii:
“Please note that abstracts presented at conferences and/or in journal supplements (such as study design and results analyses) that have not been subject to independent review are generally regarded as not having sufficient evidence to support claims and may not be used as reference in APS.”

The review would require PAAB to see the full published peer-reviewed study and the abstract to ensure the study is acceptable and subsequently, the link to the abstract is acceptable.

Jennifer Carroll

Hello @adelaidebaker

As a general principle, the clinical decision to prescribe or switch should be made based on clinical considerations. Patient preference can be a part of a patient profile but should not be positioned as the reason to prescribe or switch. Patient preference can be presented as a consideration, without drawing conclusions about clinical actions.
With respect to the specific case presented in the question, the copy in the guidelines and the APS would have to be assessed at the time of submission. We’d caution that “broadly defined” may be problematic and that drawing inference around patient choice such as “difficulty remembering to take pills and therefore might prefer injections” would require statistically significant evidence from a published high quality source.

Jennifer Carroll

Good Afternoon @Manufacturer and @Agency

It's crazy to say but we're now just past halfway through 2025!

The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q2. See the Tag report here and the CEI report here.

The Forum Quarterly Review for Q2 has also been posted here.

If there's more you'd like to know in Q3, let us know in the comments below. Have a wonderful rest of the summer.

Thank you
PAAB

Forum

administrators

Posts

Member List