FDA Approves Celltrion and Teva's Trastuzumab Biosimilar, Herzuma

The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer.

“Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy,” said Woosung Kee, CEO of Celltrion, in a statement announcing the approval. “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.”

Approval of the drug was based on a data package that included efficacy, safety, immunogenicity, pharmacodynamic, and pharmacokinetic data from trials conducted in over 500 patients in 22 countries. A phase 3 equivalence trial of the biosimilar as a neoadjuvant treatment in HER2-positive early breast cancer demonstrated equivalent efficacy of the proposed biosimilar with the reference trastuzumab, with a similar proportion of patients achieving pathological complete response in the trial’s 2 arms.

A similar proportion of patients receiving the biosimilar and the reference experienced serious treatment-emergent adverse events (TEAEs) (7% in the biosimilar group versus 8% in the reference group), with the most frequently reported TEAE being neutropenia (4% versus 5%, respectively).

The approval of the drug follows disappointment for Celltrion earlier this year; in April 2018, the FDA issued a Complete Response Letter (CRL) for Herzuma following a Form 483 that noted 12 observations related to the company’s manufacturing process. After working together with the regulator to address the issues found in the CRL, Celltrion resubmitted its Biologics License Application for the drug in June 2018.

While the reference product is also approved for the treatment of HER2-positive gastric cancer, Herzuma did not gain approval in this indication. Earlier this year, the FDA also approved Celltrion’s rituximab biosimilar, Truxima, with a “skinny label” that included fewer indications than its reference. At the time, Celltrion indicated that it had elected to seek fewer than all indications for its product due to intellectual property issues.

Herzuma is the second FDA-approved trastuzumab biosimilar, following Mylan and Biocon’s approval for Ogivri in December 2017 (Ogivri has not yet launched in the United States). Herzuma has also earned approval in the European Union (where it is marketed by Mundipharma), in Japan (where it is marketed by Daiichi Sankyo), and in Australia.