Roche

Sep 18, 2023

Sandoz receives EMA CHMP approval for Herceptin biosimilar Roche’s monoclonal antibody therapy has been approved for treating HER2-positive breast cancer and metastatic gastric cancers. Herceptin generated Sfr878m ($980m) in global sales in H1 2023, as per Roche’s Q2 financial report. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Sandoz’s Herceptin (trastuzumab) biosimilar for European marketing approval. Herceptin is a monoclonal antibody that binds to the human epidermal growth factor receptor 2 positive (HER2) receptors to prime them for being targeted by the immune system. It has been approved for the treatment of HER2-positive breast cancer and metastatic gastric cancers. Herceptin generated Sfr878m ($980m) in global sales in H1 2023, as per Roche’s Q2 2023 financial report . Recommended Reports The Herceptin biosimilar was developed by EirGenix and is licensed by Sandoz. While EirGenix holds the developmental and manufacturing rights, Sandoz is responsible for the commercialisation of the biosimilar. The CHMP recommendation is based on the Phase I and III studies in patients with breast cancer showing that the biosimilar is non-inferior to the reference biologic. In 2019, the US Food and Drug Administration (FDA) approved Amgen and Allergan’s Herceptin biosimilar, Kanjinti . The sales for the biosimilar pales in comparison to the Herceptin sales, with Amgen reporting $50m in sales for Q2 2023 for Kanjinti, as per the company’s Q2 financial report .