The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer.
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.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.