# FDA Approves Organon's ONTRUZANT (Trastuzumab) Biosimilar The FDA has approved Organon LLC's ONTRUZANT (trastuzumab), a biosimilar to Herceptin, marking another competitive entry into the HER2-positive cancer treatment market and potentially increasing pricing pressure on the originator biologic. The intravenous biosimilar approval expands treatment options for breast and gastric cancer patients while offering healthcare systems and payers an opportunity to reduce costs for this widely-used oncology therapeutic.