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FDA panel: PSGs can recommend bridging and modeling when reference product is discontinued
Summary
FDA panelists said product-specific guidances (PSGs) can include alternative bioequivalence approaches — such as bridging studies and PK/PB modeling — when the reference listed drug (RLD) or reference standard (RS) is unavailable, and encouraged attendance at a May workshop on the topic.
A moderator asked whether FDA would develop and publish product-specific guidances (PSGs) for products whose reference listed drug (RLD) has been discontinued and for which no generics exist. Dr. Kotsabar, who responded to the question, said the agency already has PSGs that offer alternatives in those cases and expects more guidance in the future.
"In those cases, there are PSGs, that recommend alternative bioequivalence approaches with bridging studies, on sometimes the same API but different dosage forms, often based on PK, PB modeling approaches," Dr. Kotsabar said. He added that only a few such PSGs are currently available but that FDA is working to expand options so generic sponsors are not stuck when they cannot obtain a physical reference product.
Dr. Kim, another member of the panel, said the issue will be on the agenda at an upcoming FDA workshop and highlighted potassium chloride as an example where FDA has tried bridging across tablet and suspension forms. "We the agency is very aware of this challenge, and we are gonna be discussing at the May workshop," Dr. Kim said, urging industry participants to attend.
The panel framed the approaches — bridging studies, dosage-form comparisons and pharmacokinetic/pharmacodynamic (PK/PD or PK/PB) modeling — as ways to establish bioequivalence when a physical RLD or RS is unavailable. Officials did not announce new rulemaking or specific new PSGs at the session; they described the guidance work as ongoing and encouraged sponsors to monitor FDA publications and to participate in the May workshop for further detail.
