FDA Approves Hercessi, a Biosimilar to Herceptin

The Food and Drug Administration (FDA) has approved Hercessi^™ (trastuzumab-strf), a biosimilar to Herceptin^® (trastuzumab).

Hercessi, a a HER2/neu receptor antagonist, is indicated for:

• Adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with 1 high risk feature) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; or as a single agent following multi-modality anthracycline based therapy.
• In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, and as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.
• In combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

The approval of Hercessi was based on a comprehensive package of analytical, preclinical, and clinical data demonstrating that the biosimilar product is highly similar to the reference product, Herceptin. The application was supported by two phase 1 pharmacokinetic (PK) studies and a phase 3 comparability study (ClinicalTrials.gov Identifier: NCT03084237), which showed the biosimilar was equivalent, both in safety and efficacy, to the reference product in patients with HER2-positive recurrent or metastatic breast cancer. 

Hercessi is supplied as a 150mg lyophilized powder in a single-dose vial for intravenous infusion after reconstitution. The FDA is expected to make a decision on the 420mg dosage strength of Hercessi in the fourth quarter of 2024.

“The approval of Hercessi, our first biosimilar to be approved in the US, marks an important milestone for Accord BioPharma in our efforts to improve access for patients,” said Chrys Kokino, US president of Accord. “Because breast and gastric cancers are among the most common types of cancer and cancer can have a high-cost burden for patients, there is a need to provide these patients with additional treatment options that may be more affordable, such as biosimilars.”