Henlius’ biosimilar HLX02 will be used to treat HER2-overexpressing breast cancer. Credit: Nephron / Wikimedia.

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) for Shanghai Henlius Biotech’s proposed biosimilar HLX02 (trastuzumab for injection).

Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The application is seeking approval for the biosimilar to treat HER2-overexpressing metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma.

HLX02 will also be used as the adjuvant treatment of HER2-overexpressing breast cancer.

Accord US received exclusive rights for developing and marketing HLX02 in Canada and the US in 2021.

HLX02 is claimed to be the first Chinese biosimilar approved in Europe and China.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

It is currently indicated to treat HER2-positive early breast cancer, metastatic gastric cancer, and metastatic breast cancer.

Henlius president Jason Zhu said: “Henlius independently developed HLX02 in accordance with the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the FDA, and other international biosimilar guidelines.

“It is now approved in more than 30 countries and benefitted more than 100,000 Chinese patients.

“The US FDA’s acceptance of the BLA filing not only expands Henlius’ international footprint. More importantly, we prioritise the needs of patients.”

The BLA submission to the FDA is supported by the data obtained from studies conducted between HLX02 and the reference trastuzumab.

The studies include a Phase I PK similarity study, comparative analytical studies, a multicentric, international Phase III safety, efficacy, and immunogenicity study, and nonclinical studies.

In these trials, HLX02 and reference trastuzumab were found to be highly similar in terms of efficacy, safety, and quality.