In our ongoing surveys of physicians around the world, we have spotted some concerns for several physicians within India about biosimilars (the numbers will be left for a later blog post/academic article). The most obvious complaint is a simple and dangerous one – the biosmilars often did not work.
While the first biosimilar was approved in US last year, India has far more experience with the products. Indeed, the first controversy over the regulation of biosimilars was in 2001 when Dr. Reddy’s introduced a biosimilar of Roche’s Neupogen (Filgrastim). After complaints by Roche and its Indian partner, Piramal, an expert committee was constituted to examine the approval given to Dr. Reddy’s and after a detailed examination the approval was considered acceptable.
It is still unclear to me whether India even had a regulatory pathway for approving bio-similars. More than a decade after the Filgrastim controversy, India is facing yet another bio-similars controversy in a case involving approvals granted to Biocon to launch a biosimilar of Roche’s Herceptin. This time around, India does have in place Guidelines which lays down the requirements for bio-similars to enter the market. However the legality of the guidelines is highly questionable and the standards laid therein have been brought into question in the Roche-Biocon litigation. Another pressing concern however, is whether the Indian Government has done enough to amend its laws and create the long term regulatory infrastructure that is required to safely regulate bio- similars.
And given physician concern this should probably be a high priority.