On 29 April 2024, Intas subsidiary Accord BioPharma announced that the FDA has approved Hercessi™, biosimilar to Roche’s Herceptin® (trastuzumab), for the treatment of HER2-overexpressing breast and gastric / gastroesophageal junction adenocarcinoma. This is the first US biosimilar approved for Accord BioPharma.
The approval relates to the 150mg dose product with the FDA decision on the 420mg dose expected in the fourth quarter of 2024.
Accord BioPharma has submitted BLAs for biosimilars of pegfilgrastim, filgrastim, and ustekinumab with launch of the latter licensed under a settlement with Janssen from 15 May 2025.