In the development of a biosimilar product, what studies should be conducted if the manufacturing site of the reference product in PK/PD comparability study is not the same as the Taiwanese approved product?
The bridging studies have be proved to support the quality are the same between Taiwanese approved reference (R) and the PK/PD study reference (R’) where the manufacturing site is different from Taiwanese approved product.
The pharmaceutical comparison should be verified the quality similarity between Taiwanese approved reference (R), the PK/PD study reference (R’) and the biosimilar products together, and the acceptable criteria should be discussed with the regulatory authority depending on the different cases.
If the outcome of pharmaceutical comparison could not be fitting the acceptable criteria, the PK/PD comparability study is needed. The PD comparability study may be requested depending on the different cases.
Hence, prior discussion with the regulatory authority is highly recommended.
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