Looking to spur the endeavours in the biotechnology sector in line with the latest trends, the Department of Biotechnology (DBT) for the first time launched a scheme to promote the development of biosimilars by the domestic industry by extending financial support.

The first exclusive effort in the field of biosimilars is being launched under the Biotechnology Industry Partnership Programme (BIPP), a public-private partnership for support on cost sharing basis for development of novel and high risk futuristic technologies mainly for enhancing research capacities. The BIPP is part of the Biotechnology Industry Research Assistance Programme (BIRAP), a unique initiative of DBT being implemented in partnership with ABLE and BCIL to nurture R&D and innovation in Biotech Industry. Biotech Consortium India Limited (BCIL) is the BIPP Management Agency and will ensure maintenance of strict confidentiality of the proposals as per DBT norms.

The special call for biosimilars under the BIPP is aimed at product development in the field. This will include establishment and maintenance of master and working cell banks, cell culture media optimization, protein ex-pression, final and in-process product characterization techniques : e.g. charged species , isoforms , glycoforms, product, development of formulation, protein purification, bioanalytical assay development including in-vitro and in - vivo bioassays, immunogenicity assays etc, viral clearance methodologies and challenge tests - method establishment and validation, and delivery device development that are intimately associated with biologics e.g. prefilled syringes, disposable cartridges, pens, inhalers etc.

The support will also be given to evaluation in suitable cell-culture and animal model systems, clinical trials and safety, scale up activities, technology transfers, product and process validation, quality unit set-up, comparability studies, stability studies and any other innovation involved in the development of biosimilars, accord to the DBT notification.

The support will be giving to large, medium and small scale companies including the start-ups on cost sharing basis. Varying models of grants, loans or grant plus loans will be made available under the scheme.