Seeking to become the second omalizumab biosimilar to be approved in the US, Amneal Biosciences and Kashiv BioSciences announced on September 26 that they had filed a biologic licensing application for the approval of their biosimilar candidate ADL-018. “The earlier-than-expected BLA submission for this important therapeutic is excellent news for Amneal, as this product represents … Continue reading Partners Amneal and Kashiv File 351(k) Application for Omalizumab Biosimilar