Aurobindo Pharma Limited is gearing up to make its first immunology biosimilar filing in FY24/25, with regulatory approval likely to open the gateway to a $4bn opportunity for the drug in markets like Europe and US should it be among the first three companies to launch.
So far, it has filed applications for two oncology biosimilars in the European Union via its subsidiary CuraTeQ Biologics Private Ltd. The first was for a pegfilgrastim rival to Amgen, Inc
“We have advanced one of our very important immunology assets into Phase I clinical trial in Australia/New Zealand in Q4 of the last fiscal year [ended 31 March 2022], with the potential of it moving into a global Phase III trial by Q3 or Q4 of this year [FY23],” Satakarni Makkapati, CEO of Aurobindo's biosimilars, vaccines and peptides