FDA Approves HLX02, Biosimilar Trastuzumab, for HER2-Positive Cancers


Trastuzumab-strf, a biosimilar of trastuzumab, has received FDA approval for treating HER2-overexpressing breast cancer and metastatic gastric cancer.

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  • The FDA has granted approval for trastuzumab-strf (HLX02), a biosimilar of trastuzumab (Herceptin, Hercessi), for multiple indications.
  • The approval of HLX02 is backed by a series of head-to-head trials, comparative quality analytical data, a phase 1 pharmacokinetic similarity trial, and a global, multicenter, phase 3 trial (NCT03084237).
  • This approval signifies a significant milestone in expanding treatment options for patients with these types of cancers.

HLX02, a trastuzumab biosimilar, has been granted approval from the FDA as an adjuvant treatment for HER2-overexpressing breast cancer, as well as for the treatment of patients with HER2-overexpressing metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.1

This approval is supported by a series of head-to-head trials with HLX02, including comparative quality analytical data, a phase 1 pharmacokinetic similarity trial, and a global, multicenter, phase 3 trial where HLX02 was shown to be highly similar to reference trastuzumab in regard to quality, safety, and efficacy.

These data were submitted by Henlius Biotech and included a thorough submission of analytical, preclinical, and clinical data.

Dna helix enlarged model in bright colors and spots, Generative AI: © Radomir Jovanovic - stock.adobe.com

DNA helix enlarged model in bright colors and spots, Generative AI: © Radomir Jovanovic - stock.adobe.com

"Henlius independently developed HLX02 in accordance with the National Medical Products Administration [NMPA], the European Medicines Agency, the FDA, and other international biosimilar guidelines. It is Henlius’ first FDA-approved product. Our patient-centered approach has led us to unwaveringly explore high-quality, effective, affordable, and accessible treatment options, and our determination to promote HLX02 in more than 40 markets around the world is Henlius’ response to patients' concerns. We look forward to reaching more patients in North America and providing them with more cost-effective access to high-quality biologics,” said Jason Zhu, executive director, chief executive officer, and chief financial officer of Henlius, in a press release.

“Our first FDA-approved biosimilar is an important achievement for our US specialty business, but we’re just getting started. We aspire to deliver one of the deepest portfolios of biosimilars to patients and providers alike, and to help the US health system achieve significant savings,” added Binish Chudgar, vice chairman and managing director, Intas Pharmaceuticals, in the press release. “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.”

Background on HLX02

HLX02 is a Chinese-manufactured trastuzumab biosimilar. The agent, developed and manufactured by Henlius, currently is approved in more than 30 countries.

Trastuzumab is an anti-HER2 antibody given in combination with chemotherapy for patients with HER2-positive breast cancer. While the combination has significantly improved overall survival in these patients and has become the standard of care over the past decade, the cost can limit patient access.

In April 2023, the FDA accepted a biologics license application (BLA) for HLX02 for the adjuvant treatment of patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or GEJ adenocarcinoma.2 Data from a randomized, double-blind, phase 3 trial served as a part of the basis of this BLA.

The study compared HLX02 with reference trastuzumab across 89 centers in China, the Philippines, Poland, and Ukraine.3 Patients with HER2-positive recurrent or metastatic breast cancer were eligible and randomized in a 1:1 fashion to receive HLX02 or European Union (EU)-sourced trastuzumab in combination with intravenous docetaxel. The first dose was 8 mg/kg, followed by 6 mg/kg every 3 weeks for up to 12 months.

The primary end point evaluated in the trial was 24-week overall response rate (ORR). Secondary end points of the study were ORR at weeks 6, 12, 18, and 24; duration of response; disease control rate; clinical benefit rate; progression-free survival; and overall survival.

Of the 649 patients enrolled between November 11, 2016, and July 10, 2019, the 24-week ORR was 71.3% with HLX02 (n = 324) vs 71.4% for patients treated with EU-trastuzumab (n = 325), with a difference of –0.1% (95% CI, –7% to 6.9%). This fell entirely in the predefined equivalence margins.

There were no statistically significant differences in secondary efficacy analyses seen. Additionally, the safety profiles of both agents, as well as immunogenicity, were comparable.

“The approval of [HLX02]—our first biosimilar to be approved in the US—marks an important milestone for Accord BioPharma in our efforts to improve access for patients,” Chrys Kokino, US president of Accord, added in the press release.1 “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.”

1. Henlius Trastuzumab receives FDA approval in the United States. News release. Henlius Biotech, Inc. April 26, 2024. Accessed April 29, 2024. https://tinyurl.com/mv9xbkpn
2. Accord BioPharma announces U.S. FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02. News release. Accord BioPharma. April 5, 2023. Accessed April 29, 2024. https://prn.to/3KzoptP
3. Xu B, Zhang Q, Sun T, et al. Efficacy, safety, and immunogenicity of HLX02 compared with reference trastuzumab in patients with recurrent or metastatic HER2-positive breast cancer: A randomized phase III equivalence trial. BioDrugs. 2021;35(3):337-350. doi:10.1007/s40259-021-00475-w

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