The biosimilar was developed by Dr Reddy’s Laboratories and first approved in India in 2007. A collaboration was announced in 2016 of Dr Reddy’s and TRPharm, under which TRPharm will register and commercialize a total of 3 biosimilar products of Dr Reddy’s in Turkey.
In January, Turkish-based drug maker TRPharm received regulatory approval in Turkey for a rituximab biosimilar, Redditux (marketed in India as Reditux). The company has now announced that the biosimilar, indicated for the treatment of non-Hodgkin lymphoma and chronic lymphocytic lymphoma, will be launched shortly.
“The approval of Redditux in Turkey represents a historic milestone for TRPharm. At TRPharm, we understand the value of biosimilars in not only enabling access to these important therapies for more patients, but also lowering healthcare costs in one area to pae the way for newer and innovative treatments in others,” said Mehmet Goker, chairman and CEO of TRPharm in a statement.
The biosimilar was developed by Indian drug maker Dr Reddy’s Laboratories, and first approved in India in 2007. A collaboration was announced in 2016 of Dr Reddy’s and TRPharm, under which TRPharm will register and commercialize a total of 3 biosimilar products of Dr Reddy’s in Turkey.
Within 3 years of the launch of Reditux in India, the number of patients receiving the therapy increased six-fold. The rituximab biosimilar approval in India was granted followed by a single-arm clinical trial1 in which the objective response rate was demonstrated in a small group: 67 patients. Comparisons were shown with the originator product using literature searches to demonstrate similar objective response rates for the same indication. The study size and design were attributed to the high price of the reference product in India. Given the similar ranges of the response rate in the single-arm trial, Dr Reddy’s advocated a benefit-versus-risk consideration for regulatory approval versus a head-to-head comparative trial.
In more highly regulated markets, the biosimilarity of a drug must be demonstrated in adequately powered clinical trials. The noninferiority of a biosimilar alone is not considered acceptable as an outcome, because safety differences may exist. This fact gave some stakeholders cause for concern when the biosimilar rituximab was approved based on such a small sample size.
However, a retrospective analysis2 conducted in 223 patients in India with diffuse large B-cell lymphoma found that complete remission rates with the reference drug and biosimilar rituximab were similar (75% and 82%, respectively; P =.294). This analysis also revealed that there were no further differences in infusion reaction rates or grade 3 to grade 4 neutropenia. Many oncologists in India are now prescribing Reditux, leveraging the cost benefit it brings to patients to have access to the cheaper biosimilar.
1. Qureshi Z, Magwood J, Singh S, Bennett C. Rituximab and biosimilars—equivalence and reciprocity. Biosimilars. 2013;(3):19-25. doi:10.2147/BS.S20681.
2. Chopra R, Lopes G. Improving access to cancer treatments: the role of biosimilars. J Glob Oncol 2017;(5):596-610. doi: 10.1200/JGO.2016.008607