Seeking immediate revision of Biosimilar Guideline (2016) to facilitate access to quality biosimilars at an affordable price, representatives of various civil societies, community and health organisations, and patient groups have written to the Central Health Ministry and Department of Biotechnology asking it 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.’‘
A biosimilar, or biosimilar drug, is a medicine that is very close in structure and function to a biologic medicine and is safe and effective treatment options for many illnesses including arthritis, kidney conditions, and cancer. They increase access to lifesaving medications at potentially lower costs.
“The incorporation of the new revised World Health Organisation (WHO) Biosimilar Guidelines in the Indian regulatory framework presents tremendous opportunities for manufacturing to introduce affordable, safe and efficacious biosimilars,’‘ said the group in its letter issued on Friday.
It added that 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 such as oncology monoclonal antibodies range from ₹2 lakh onwards per cycle and the cost for gene therapies is exorbitantly high. The National Policy for Rare Diseases, 2021 from the Ministry of Health also recognises the high cost of medicines for rare diseases. Hence access to these drugs is severely limited.
“The reform in Indian guidelines where we can do away with animal studies and comparative clinical trials — in line with U.K. and WHO guidelines — would reduce the time and cost of biosimilar development. Further, it reduces the entry barriers and allows more companies to enter into the biosimilar market. This would increase the competition and reduce the prices and access of these critical medicines at an affordable price,’‘ explained K.M. Gopakumar, researcher on access to medicine issues.
The letter noted that by doing away with comparative efficacy studies and in vivo animal toxicity studies, the cost of production of biosimilars will go down and significant savings from streamlined biosimilar development can be achieved while maintaining the safety and efficacy of the biosimilar product.
“This will facilitate affordability and access of biotherapeutic products to patients in need of such treatments. After the U.K. and WHO in December 2022 U.S. signed a legislation, which removed the animal studies requirements for biosimilar marketing approval and similarly Canada also does not require animal studies for biosimilar approval,’‘ said the letter.
