Bioequivalence and Bioavailability Forum

Dear Experts,

We are developing generic oral tablets formulation for one of the biosimilar product. However, API that we will use in our product will be synthetic while in RLD it is r-DNA based API.

For EMA submission, which guideline should we follow to derive clinical pathway considering above? I have come across various guidelines such as 1) Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins, 2) Guideline on similar biological medicinal products, 3) Biosimilars in the EU: Information guide for healthcare professionals. But not sure if i am referring to the correct guidelines.

Is there a need to conduct toxicology and immunogenicity study or only BE study will be suffice?

Looking forward for valuable feedback.

Regards,
QA