The rationale for the choice of the reference biologic should be provided by the manufacturer of the similar biologic in the submissions to the DBT and CDSCO. The following factors should be considered for selection of the reference biologic:
The reference biologic should be licensed in India and should be innovator product. The reference biologic should be licensed based on a full safety, efficacy and quality data. Therefore another similar biologic cannot be considered as a choice for reference biologic.
In case the reference biologic is not marketed in India, the reference biologic should have been licensed and widely marketed for 4 years post approval in innovator jurisdiction in a country with well-established regulatory framework. In case no medicine or only palliative therapy is available or in national healthcare emergency, this period of 4 years may be reduced or waived off.
The same reference biologic should be used throughout the studies supporting the safety, efficacy and quality of the product (i.e. in the development programme for the similar biologic)
The dosage form, strength and route of administration of the similar biologic should be the same as that of the reference biologic.
The active substance (active ingredient) of the reference biologic and that of the similar biologic must be shown to be similar.