FDA approves Hercessi as latest interchangeable Herceptin biosimilar
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The FDA has approved trastuzumab-strf as a biosimilar to trastuzumab for the treatment of certain patients with HER2-overexpressing malignancies, according to a press release from the agent’s manufacturer.
Trastuzumab-strf (Hercessi, Accord BioPharma/Intas Pharmaceuticals) is indicated for the adjuvant treatment of HER2-overexpressing breast cancer, treatment of HER2-overexpressing metastatic breast cancer and treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
“The approval of Hercessi — our first biosimilar to be approved in the U.S. — marks an important milestone for Accord BioPharma in our efforts to improve access for patients,” Chrys Kokino, U.S. president of Accord, said in the release. “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.”
The agent works by binding to and inactivating the HER2 receptor to slow down cell replication.
The agency granted approval based on analytical, preclinical and clinical data that showed trastuzumab-strf and trastuzumab (Herceptin, Genentech) to be highly similar in efficacy, safety and quality. Data supporting the approval provided to the FDA included results from two phase 1 comparative single-dose pharmacokinetic equivalent studies conducted in healthy volunteers, as well as a supportive, double-blind, phase 3 study that showed clinical efficacy and safety among patients with HER2-overexpressing metastatic breast cancer in combination with docetaxel.
Hercessi received FDA approval at a dosage of 150 mg; a 420 mg version is currently in development with an anticipated FDA decision in late 2024.
“Our first FDA-approved biosimilar is an important achievement for our U.S. specialty business, but we're just getting started,” Binish Chudgar, vice chairman and managing director of Intas Pharmaceuticals, said in the release. “We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the U.S. health system achieve significant savings. Our vision to make affordable medicines available forms the bedrock of the company, and this work advances that vision to provide value and promote access for all the key stakeholders we engage along the treatment journey.”
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