First FDA approval for Accord biosimilar
Accord BioPharma - the US specialty division of Intas Pharmaceuticals - has won US Food and Drug Administration (FDA) approval for Hercessi (trastuzumab-strf), a biosimilar to Roche’s (ROG: SIX) Herceptin (trastuzumab).
Hercessi is indicated for the adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer and to treat HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
"Our vision to make affordable medicines available forms the bedrock of the company"HER2 cancers in general are particularly aggressive cancer types that respond well to targeted treatment. Hercessi works by binding to and inactivating the HER2 receptor, slowing down cell replication.
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