The new guideline only holds a few changes but those are quite important. One of them is the following: Similar Biologic can only be developed against an authorized Reference Biologic that has been approved using a complete data package in India. In case the Reference Biologic is not authorized in India, it should have been approved/licensed and marketed in an ICH country.
More changes can be found in the section Post-market Data for Similar Biologics. A risk management plan consisting of
should be implemented.
The intention is to reduce the residual risk of the similar biologic. Also included are a timeframe and a call for specific post-marketing safety data. A single arm study of generally more than 200 evaluable patients has to be carried out and compared to historical data of the reference product. The study should preferably be completed within 2 years.
In the area of Manufacturing, the section on “Fermentation Process Development” is now named “Upstream Process Development” but there are no substantive amendments.