Julie Reed On How the Biosimilars Forum is Helping FDA Catch Up on Biosimilar Inspections

Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.

Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.

Transcript

What should the FDA be doing to address the current backlog of inspections for biosimilar manufacturing facilities?

Reed: So, as we finished negotiations for the user fee, after that, we found out that biosimilar inspections were quite delayed. And unfortunately, if there's a delay in an inspection, there's a delay in approval of a biosimilar. And the biosimilar program inspections were the lowest—a little bit over 60%. So, we have multiple probe biosimilar applications that are not approved because the FDA did not do the inspection. Now, [we] completely understand about COVID-19, everything else, but what we're doing is advocating for the FDA—as part of user fees—we're advocating for the FDA to address this in a couple of ways.

One, FDA has a plan to do remote inspections. We're asking them to be sure that biosimilars inspections are always treated equitably, that we're not put on the bottom of the list and we're not deprioritized, and to use the process and procedures for remote inspections. The COVID-19 pandemic was tough, but we do believe that this won't be our first, unfortunately.

The other piece about the inspections, as we have heard from the FDA in our meetings, is that they plan to get all of the inspection backlog completed by the end of this year for fiscal year. So, we are cheering them on and also going to hold them accountable to do that, and especially with biosimilars because they're so important for patients and like we said cost savings. But yes, that's a key piece for us, to get those inspection backlogs up to date and completed for biosimilars.

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