Celltrion and Teva’s Herceptin biosimilar secures FDA approval in breast cancer

pharmafile | December 18, 2018 | News story | Manufacturing and Production, Sales and Marketing Herceptin, Herzuma, Teva, celltrion, pharma 

Israeli and South Korean-based drug makers Teva and Celltrion are set to move in on the market share occupied by Roche and Genentech’s Herceptin (trastuzumab) with the announcement that their own biosimilar version of the drug has received approval from the FDA.

Herzuma, as the HER2/neu receptor antagonist biosimilar is known, was shown through a “comprehensive data package inclusive of foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety data” to be clinically non-inferior to its reference product.

The pair’s drug has been approved for the following indications:

–          In adjuvant breast cancer of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer, as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, and as part of a treatment regimen with docetaxel and carboplatin.

–          In metastatic breast cancer 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 one or more chemotherapy regimens for metastatic disease.

“Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy,” stated Woosung Kee, Chief Executive Officer of Celltrion. “This is our second oncology biosimilar approval in the United States in the past month, which reinforces the goal for all of our approved products, providing broader treatment options for patients and the providers who treat them.”

Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva, added: “We are excited about building Teva’s presence in biosimilars. The addition of Herzuma to our biosimilars portfolio will allow us to leverage our strengths from oncology and generics.”

Matt Fellows

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