Bioequivalence and Bioavailability Forum

Dear Members,

We are currently in the API selection phase for the development of oral semaglutide tablets. The reference product utilizes a recombinant DNA (rDNA)-based API, and we are evaluating between two sources: an rDNA-derived API and a synthetic peptide-based API.

As a generic developer, we would appreciate your insights on which API source would be more appropriate to facilitate a smoother clinical development and regulatory pathway.

Additionally, if the selected API supplier provides sufficient evidence of API sameness and demonstrates that the impurity profile is comparable to the reference product, would a bioequivalence (BE) study alone suffice? Or would there still be a need for toxicity or immunogenicity studies?

We would be grateful for your expert opinion on this matter.

Note: According to the EMA Public Assessment Report (PAR) of the reference product, there is no indication of immunogenicity-related concerns for oral semaglutide.

Regards,
QA