Biosimilars

The Indian biosimilar market is forecasted to reach $580 million by 2012.  There are two key factors that can work favourably for Indian biosimilar companies in the domestic market. One is the relative cost advantage of biosimilar development compared to their competitors elsewhere and the second factor is the relatively lower regulatory requirements for establishing bioequivalence, which also helps to keep their development costs low. India is a semi-regulated market with respect to biosimilars. The Department of Biotechnology (DBT) is now waiting for draft notes on clinical trials for biosimilars from the Drug Controller General of India (DCGI) to complete this work on guidelines.

 

A dedicated and experienced JSS Medical Research India Ltd. team has been set-up to conduct studies for evaluation and efficacy of biosimilars. To guide sponsors in clinical planning, our medical and scientific experts draw on a deep understanding of the product’s basic underlying science with insights from specific therapeutic expertise. Our regulatory team knows the global regulatory outlook for biosimilars and uses this expertise to develop solid regulatory strategies. The approach to patient recruitment for biosimilar trials employs a combination of planning strategies and various tools like our extensive global investigator database, to meet or exceed patient enrollment objectives.

 

Our core team of biologics experts and project managers makes it possible to carry out the development program of biosimilars, keeping in mind the interest of our sponsors.