Indian Biosimilars Guidelines were introduced at BIO 2012 event last week and now, they are officially published at India’s Department of Biotechnology (DBT) and Central Drugs Standard Control Organisation (CDSCO) websites.
The guidelines were developed in coordination with the industry and academics; the full list of task force members are also published transparently in the guideline.
The “Guidelines on Similar Biologics” prepared by CDSCO and DBT set up the regulatory pathway for a biologic claiming to be similar to an already authorized reference biologic . The guidelines address the regulatory pathway regarding manufacturing process and quality aspects for biosimilars in India.
Indian biosimilars guidance also address the pre-market regulatory requirements (i.e. comparability exercise for quality, pre-clinical and clinical studies) and post market regulatory requirements for biosimilars.
Similar biologics 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 licensed and marketed for at least 4 years with significant safety and efficacy data.
According to the new Indian guideline, in case of no medicine or only palliative therapy is available or in national healthcare emergency, this period of 4 years may be reduced or waived off. Any product can be considered as similar biologic only if it is proven to be similar using extensive quality characterization against the reference biologic. Further product development should only be considered once the similarity of the product/molecule is demonstrated in quality. The guidelines are applicable for similar biologics developed in India or imported into the country.
At BIO 2012, DBT Secretary Maharaj Bhan said: ”India needs drugs at reasonable prices so we have to worry about the issue of access so we have to spur innovation and manufacturing in India. We also need to create an environment where international companies will be interested in using India as a place to manufacture drugs.”
“For me this (new guideline) creates an pathway for local and international companies to invest in biosimilar development with manufacturing in India.”