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FDA Approves 420-mg Dosage of Trastuzumab-strf Biosimilar for HER2-Overexpressing Cancers

• The FDA has approved the 420-mg strength of trastuzumab-strf (Hercessi), a biosimilar to trastuzumab (Herceptin), for HER2-overexpressing cancers. • This approval expands the availability of trastuzumab-strf, which was initially approved in a 150-mg dose in April 2024. • Trastuzumab-strf is now approved for metastatic breast and gastric/gastroesophageal junction cancers that overexpress HER2. • The approval is based on data from pharmacokinetic similarity trials and a phase 3 trial demonstrating comparable safety and efficacy to the reference product.

The FDA has granted approval for the 420-mg strength of trastuzumab-strf (Hercessi), a biosimilar to trastuzumab (Herceptin), for the treatment of HER2-overexpressing cancers. This approval encompasses metastatic breast and gastric/gastroesophageal junction cancers where HER2 overexpression is confirmed.
This decision by the FDA broadens the accessibility of trastuzumab-strf, initially approved as a 150-mg dose in April 2024. The biosimilar aims to provide a more affordable alternative for patients requiring trastuzumab-based therapy.

Clinical Data Supporting Approval

The initial approval of the 150-mg dose was underpinned by data derived from a phase 1 pharmacokinetic (PK) similarity trial and a global, multicenter, phase 3 trial (NCT03084237). These trials demonstrated PK similarity that met the FDA's biosimilar guidance criteria. Furthermore, the safety profile of trastuzumab-strf was found to be comparable to that of the reference product, Herceptin.

Industry Perspective

"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," stated Chrys Kokino, US president of Accord, in a press release. Kokino also emphasized the financial burden of cancer therapies and the company's commitment to providing more affordable options like trastuzumab-strf.
Jason Zhu, MD, executive director and chief executive officer of Henlius, highlighted the collaborative success with Accord, stating, "This represents an important step in our journey to meet the needs of patients with innovative, high quality, and affordable therapeutics."

Trastuzumab Biosimilars Landscape

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

[1]
FDA Approves New Dosage of Trastuzumab Biosimilar for HER2-Overexpressing Cancers
targetedonc.com · Sep 19, 2024

The FDA approved the 420-mg strength of trastuzumab-strf, a trastuzumab biosimilar, for HER2-overexpressing cancers. Pre...

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