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The United States Food and Drug Administration (FDA) has approved a new medicine called trastuzumab-strf (HLX02, brand name Hercessi). This new medicine is very similar to an existing cancer treatment called trastuzumab (brand name Herceptin).

Medicines like HLX02 that are highly similar to already approved treatments are known as “biosimilars”. Biosimilars can provide more affordable treatment options for patients since their development costs are lower than bringing an entirely new drug to market.
HLX02 has been approved to treat two different types of cancers that overexpress the HER2 protein:

  • It can be given to breast cancer patients after surgery to help prevent the cancer from coming back. This is known as adjuvant therapy.
  • It can also be used to treat breast cancer that has spread to other parts of the body (metastatic).
  • Additionally, HLX02 can treat stomach cancer and cancers in the area where the stomach meets the esophagus, when these cancers have spread to distant sites in the body.

Both HLX02 and the original trastuzumab work by targeting a protein called HER2 that promotes cancer cell growth. Blocking HER2 can stop these cancers from worsening and help existing tumors shrink. HER2 overexpression occurs in about 20% of breast cancers.

The FDA based its approval on a comprehensive scientific evidence package showing HLX02 is highly similar to trastuzumab in quality, safety, and effectiveness. This data came from analytical studies directly comparing the structural and functional characteristics of the two medicines, as well as clinical trials evaluating HLX02 in patients.

One main clinical trial enrolled 649 patients with HER2-positive metastatic breast cancer. It found that 71.3% had their cancers shrink or stop growing after 24 weeks of HLX02 treatment. This overall response rate was virtually identical to patients receiving the original trastuzumab.

HLX02 was developed and manufactured by a biopharmaceutical company called Henlius Biotech based in Shanghai, China. It has already been approved for use in China since August 2020 and in Europe since July 2020 under the brand name Zercepac.

“Providing high-quality, affordable biologics to more patients worldwide is a top priority for Henlius,” said Jason Zhu, CEO of the company. Henlius now aims to make HLX02 available in over 40 countries globally.

The US approval allows the specialty pharmaceutical company Accord BioPharma to market HLX02 under the brand name Hercessi for approved uses in breast and gastric cancers.
“This biosimilar approval expands access to targeted treatment against HER2-positive cancers that can impose a significant cost burden,” said Chrys Kokino, US President of Accord BioPharma.

With its proven high similarity to the original trastuzumab product, the newly FDA-approved HLX02 biosimilar Hercessi is expected to be priced lower than its reference product, increasing affordable treatment options for breast and stomach cancer patients in the United States.


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