Biosimilars Quiz

Which of the following statements regarding extrapolation is correct?

1. Extrapolation is the extension of clinical data from one indication to another
2. Extrapolation is the extension of clinical data from the reference molecule to the biosimilar
3. The mechanism of action of the active substance is different in the tested and extrapolated indications
4. Extrapolation of indications is automatically awarded to the biosimilar upon approval