FDA Approves New Dosage of Trastuzumab Biosimilar for HER2-Overexpressing Cancers

Tumor microenvironment concept: © ratatosk - stock.adobe.com

• The FDA has approved the 420-mg strength of the trastuzumab (Herceptin) biosimilar trastuzumab-strf (Hercessi; formerly HLX02).
• The agent is approved to treat HER2-overexpressing cancers.
• In April 2024, the FDA approved the 150-mg dose of trastuzumab-strf.

Trastuzumab-strf, a trastuzumab biosimilar, at 420 mg has been approved by the FDA for the treatment of HER2-overexpressing cancers, including metastatic breast and gastric/gastroesophageal junction cancers.¹

"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," said Chrys Kokino, US president of Accord, in a press release. "Although each [patient with cancer] 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 [trastuzumab-strf].”

In April 2024, the FDA approved the 150-mg dose of the trastuzumab biosimilar. This initial approval was supported by data from a phase 1 pharmacokinetic (PK) similarity trial and a global, multicenter, phase 3 trial (NCT03084237). The PK similarity in these trials met the FDA’s biosimilar guidance. Further, the safety profile of trastuzumab-strf was observed to be comparable to the reference product.

"The strength and success of our collaboration with Accord continues with the approval of the 420 mg strength of [trastuzumab-strf]. This represents an important step in our journey to meet the needs of patients with innovative, high quality, and affordable therapeutics,” said Jason Zhu, MD, executive director and chief executive officer of Henlius, said in the press release.

Trastuzumab-strf was the first FDA-approved biosimilar from Accord BioPharma, and the company has also submitted biologics license applications for biosimilar versions of pegfilgrastim (Neulasta), filgrastim (Neupogen), and ustekinumab (Stelara). Additional trastuzumab biosimilars are approved in the US, including include trastuzumab-anns (Kanjinti), trastuzumab-dttb (Ontruzant), trastuzumab-qyyp (Trazimera), trastuzumab-pkrb (Herzuma), and trastuzumab-dkst (Ogivri).²

REFERENCES:

1. 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 cancer. News release. Accord BioPharma, Inc. September 18, 2024. Accessed September 19, 2024. https://tinyurl.com/y2vnmud9

2. Biosimilars. Susan G. Komen. Accessed September 19, 2024. https://tinyurl.com/ydtzkjzx