FDA Approves Trastuzumab Biosimilar for Breast Cancer

By Cassie Homer
Save to PDF By

The FDA approved trastuzumab-pkrb, a HER2/neu receptor antagonist biosimilar to trastuzumab, for the treatment of certain patients with breast cancer, according to the manufacturers.

The approval includes indications for the adjuvant treatment of patients with HER2-overexpressing breast cancer in combination with doxorubicin, cyclophosphamide and either paclitaxel or docetaxel, or in combination with docetaxel and carboplatin. Trastuzumab-pkrb is also approved for patients with HER2-overexpressing metastatic breast cancer as a first-line treatment in combination with paclitaxel or as a single agent for patients with HER2-overexpressing breast cancer who have received one or more chemotherapy regimens for metastatic disease.


​Chemotherapy drip. Source: Getty

Trastuzumab-pkrb will be marketed as Herzuma.

“Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy,” Woosung Kee, Chief Executive Officer of Celltrion, said in a press release. “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.”

The FDA based the approval of trastuzumab-pkrb on a review of foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety data. Analyses showed no clinically meaningful differences between trastuzumab-pkrb and the reference product.

Trastuzumab products carry a boxed warning that states treatment with the drug may be associated with cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.