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.
