Posted by Michael Wonder on 07 Oct 2025
Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)
6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and the EMA has accepted the marketing authorisation application, for ADL-018, a proposed biosimilar to Xolair (omalizumab).
The submissions are intended to seek approval in the US and the European Economic Area, respectively.
