Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear group,

As part of our global biosimilar monoclonal antibody development, scientific bridging between U.S. and non-U.S.-licensed comparator product including comparative physicochemical characterization, biological assays/functional assays, degradation profiles under stressed conditions and clinical pharmacokinetic (PK) study was planned as per FDA guidance for industry - Questions and Answers on Biosimilar Development and the BPCI Act, Q.I.8.
However due to challenges in sourcing U.S licensed product, conducting comparative clinical PK study is not feasible. Is it acceptable to the FDA if we justify the bridging studies only with comparative analytical studies?

Thank you very much for your insights!

Please check the manufacturing site listed for the RLD biologic if both the US sourced and EU sourced products are from the same site. Or are they from different companies?

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GRSAOnline
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Original Message:
Sent: 16-Dec-2021 06:35
From: Anonymous Member
Subject: Scientific bridging for establishing biosimilarity for BLA

This message was posted by a user wishing to remain anonymous

Dear group,

As part of our global biosimilar monoclonal antibody development, scientific bridging between U.S. and non-U.S.-licensed comparator product including comparative physicochemical characterization, biological assays/functional assays, degradation profiles under stressed conditions and clinical pharmacokinetic (PK) study was planned as per FDA guidance for industry - Questions and Answers on Biosimilar Development and the BPCI Act, Q.I.8.
However due to challenges in sourcing U.S licensed product, conducting comparative clinical PK study is not feasible. Is it acceptable to the FDA if we justify the bridging studies only with comparative analytical studies?

Thank you very much for your insights!