As stated in the adopted EU guideline: EMEA/CHMP/BMWP/42832/2005: Guideline on similar biological medicinal products Containing Biotechnology-Derived Proteins as Active Substances: Non-Clinical and Clinical Issues

"In case the originally authorised medicinal product has more than one indication, the efficacy and safety of the medicinal product claimed to be similar has to be justified or, if necessary, demonstrated separately for each of the claimed indications. In certain cases, it may be possible to extrapolate therapeutic similarity shown in one indication to other indications of the reference medicinal product. Justification will depend on e.g., clinical experience, available literature data, whether or not the same mechanisms of action or the same receptor(s) are involved in all indications. Possible safety issues in different subpopulations should also be addressed."