News about GMP/cGMP


CDSCO India Publishes Draft to Biosimilars

The Central Drug Standard Control Organization CDSCO of India has published a new Guideline on Similar Biologic. The 58-pages document will replace the previous guidance issued in 2012. The new version is now open for discussion until April 30, 2016.


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

  • a pharmacovigilance plan
  • adverse drug reaction reporting
  • post-marketing studies (phase IV study)

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.


CDSCO: Guideline on Similar Biologic



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