Development and Commercialization of Biosimilars in India: Current Regulatory and Clinical Experience

Biologicals and Biosimilars in Hematology: The Case of Rituximab

“…Due to political lobbying and constraints in legislation (induced again by political lobby) the FDA was hardly able to develop a flourishing biosimilar pathway. 12 The predominantly profit-driven healthcare market is very biosimilar unfriendly. Of the 17 US-licensed biosimilars, only 7 are available on the market, and only 2 are more or less a commercial success.…”

“…European research has shown the way to set up an implementation program for biosimilars, based on “The Rule of Four” 12 . The following 4 principles work together to create a successful biosimilars policy in the hospital.…”

“…In the case of biosimilars this is not true. Due to political lobbying and constraints in legislation (induced again by political lobby) the FDA was hardly able to develop a flourishing biosimilar pathway 12 . The predominantly profit‐driven healthcare market is very biosimilar unfriendly.…”

Biosimilar Current Status in India

“…Biosimilar therapeutic products include insulin, erythropoietin, chorionic gonadotropin, streptokinase, interferon, and heparin. The growing biosimilars market offers huge potential for companies involved in manufacturing, research, and development [18]. After completion of the clinical study detailed reports should be submitted to DCGI.…”

Terminology for biosimilars–a confusing minefield

“…However this is often not done. For example, in a recent review of the current development of 'biosimilars' in India [14], a number of products produced and sometimes approved in India, including fi lgrastim, epoetins, interferons and a monoclonal antibody are listed as biosimilars even though the limitations described for the above mentioned Indian Wepox/PRCA case also apply to these products. Again, this is a clear misuse of terminology.…”