India's biogenerics industry poised to exploit opportunities

Expensive medicines that can generate billions of dollars in sales for drugmakers and the US Supreme Court's decision to speed access to copycat biologic drugs has found an echo in India, with the Indian biogenerics industry poised to exploit the opportunity similar to the generics potential, reports The Pharma Letter’s India correspondent.

Exactly a year after India's Central Drugs Standard Control Organization (CDSCO) issued new guidelines for biosimilar drug development that eases the required procedures for bringing drugs from clinical trials to market, a healthy debate has ensued in India with regards to biosimilar approvals.

The CDSCO recently approved registration of the first rituximab biosimilar fully manufactured by Biocad, a Russian biotech company. Supplies of the medicine are scheduled to begin early September 2017. Biocad has obtained a permanent marketing authorization for the drug in India. Currently, the market of rituximab in India has grown by 8% a year and is worth over $40 million. Over the next five years, the figure is expected to swell to $58 million.