A couple of significant 351(k) applications were accepted by the Food and Drug Administration in the month of October for denosumab biosimilars. Teva announced that its applications for denosumab candidate TVB-009P were accepted by the European Medicines Agency as well as the FDA in early October. The application included data from a phase 3 trial … Continue reading New Denosumab Applications Filed, New Ustekinumab Biosimilar Approved