FDA Approves New Dose Strength of Herceptin Biosimilar for HER2-Overexpressing Breast, Gastric Cancers

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The FDA has approved Accord BioPharma's 420 mg strength Hercessi (trastuzumab-strf), a biosimilar to Herceptin, for the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast and gastric cancers.¹ The regulatory action follows the April 2024 FDA approval of 150 mg strength Hercessi for the same indication.²

The biosimilar now has approved indications for HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer (mBC), and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

"At Accord BioPharma, we are deeply committed to helping patients gain access to the medicines they need, and we will continue our efforts to help all stakeholders recognize the promise of biosimilars," Chrys Kokino, US president of Accord, said in a press release. "Although each cancer patient is unique, the cost of oncologic therapies often adds a significant burden on top of other existing challenges. We strive to respond to those needs with biosimilars like Hercessi."¹

The approval was based on findings from three studies that provided comprehensive analytical, preclinical, and clinical data, demonstrating equivalence between Hercessi and reference Herceptin in terms of efficacy, safety, and quality, according to Accord. These included a pair of Phase I comparative single-dose pharmacokinetic (PK) studies conducted in healthy participants—HLX02-HV01 and HLX02-HV02—as well as the supportive double-blind, randomized HLX02-BC01 Phase III trial. HLX02-BC01 analyzed efficacy and safety comparability data among patients with HER2-overexpressing mBC in combination with docetaxel. Investigators found that the PK comparability and clinical efficacy and safety data shown in the HLX02-HV02 and HLX02-BC01 trials adhere to the current biosimilar guidance from the FDA.

In terms of safety, the profile of Hercessi was consistent with the known safety profile of reference Herceptin. Data show no clinically meaningful differences between the biosimilar and reference product, which supports the biosimilarity between the two drugs, according to Accord.

Hercessi was originally developed by Shanghai Henlius Biotech, with exclusive rights to develop and commercialize the drug in the United States and Canada granted to Accord in 2021.³

"The strength and success of our collaboration with Accord continues with the approval of the 420mg strength of Hercessi,” said Dr. Jason Zhu, executive director and CEO of Henlius in a press release. “This represents an important step in our journey to meet the needs of patients with innovative, high quality, and affordable therapeutics."¹

The impact of approved biosimilars on drug pricing has been significant. A study released last year by the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics and published in Health Affairs compared trastuzumab to five biosimilar entrants. Investigators found that the reference trastuzumab began losing market share immediately after the biosimilar Kanjinti (trastuzumab-anns; Amgen) launched, and continues to lose market share to the other approved biosimilars.⁴

“With multiple biosimilar competitors entering the US market quickly, trastuzumab is the best example to date of biosimilars fulfilling their promise to reduce biologic drug prices,” said Alice Chen, PhD, associate professor and vice dean for research at the Sol Price School of Public Policy at the University of Southern California, in a press release. “In just three years, the trastuzumab market displayed important hallmarks of competition: doctors could choose among six products; new entrants rapidly captured market share from the originator; and prices steadily declined on all six options. Prices of some versions declined by more than half, and the originator lost half of the market.”⁴

References

1. Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of 420mg Strength of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), for the Treatment of Several Forms of HER2-Overexpressing Cancer. News release. Accord BioPharma. September 18, 2024. Accessed September 18, 2024. https://prnmedia.prnewswire.com/news-releases/accord-biopharma-inc-announces-us-food--drug-administration-approval-of-420mg-strength-of-hercessi-trastuzumab-strf-a-biosimilar-to-herceptin-trastuzumab-for-the-treatment-of-several-forms-of-her2-overexpressing-cance-302251163.html

2. Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab) for the Treatment of Several Forms of HER2-Overexpressing Cancer. PR Newswire. April 29, 2024. Accessed September 18, 2024. https://www.prnewswire.com/news-releases/accord-biopharma-inc-announces-us-food--drug-administration-approval-of-hercessi-trastuzumab-strf-a-biosimilar-to-herceptin-trastuzumab-for-the-treatment-of-several-forms-of-her2-overexpressing-cancer-302129508.html

3. Accord BioPharma Announces U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar Trastuzumab HLX02. PR Newswire. April 5, 2023. Accessed September 18, 2024. https://www.prnewswire.com/news-releases/accord-biopharma-announces-us-fda-acceptance-of-biologics-license-application-for-proposed-biosimilar-trastuzumab-hlx02-301790459.html

4. Biosimilars drug market isn’t broken after all, USC Schaeffer study finds. News release. EurekAlert. June 6, 2023. Accessed September 18, 2024. https://www.eurekalert.org/news-releases/991617