A team of experts from All India Drug Action Network, Drug Action Forum-Karnataka, Working Group on Access to Medicines and Treatments, etc. have written to the governmen to immediately take steps to revise the Biosimilar Guideline of 2016 and facilitate access to quality biosimilars at an affordable price.

In this regard, a request has been made to form a committee free from the influence of innovator biologic manufacturers who have a clear conflict of interest promoting the originator products which are exorbitantly priced and clearly out of reach of most Indian people.

The incorporation of the new revised WHO Biosimilar Guidelines in the Indian regulatory framework presents tremendous opportunities for manufacturing to introduce affordable, safe and efficacious biosimilars.

Biologics are the fastest-growing class of medications and account for a substantial and growing portion of health care costs. However, the price of some of the biological therapies like oncology monoclonal antibodies range from Rs 2 Lakh to 3.39 lakh per cycle and the cost for gene therapies is exorbitantly high. 

Representatives of various civil society, community organisations, health organisations and patient groups have raised concerns that the steep price decline that is evident in case of generic drugs is not visible in the biosimilar medicines.