The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met:
Similarity with respect to quality has been proven to reference biologic
Similarity with respect to preclinical assessment has been proven to reference biologic
Clinical safety and efficacy is proven in one indication
Mechanism of action is same for other clinical indications
Involved receptor(s) are same for other clinical indications
New indication not mentioned by innovator will be covered by a separate application.