Samsung Bioepis secures FDA approval for cancer drug Ontruzant

The US Food and Drug Administration (FDA) has granted approval for Samsung Bioepis to use Ontruzant (trastuzumab-dttb) to treat a range of cancers.

Ontruzant, which will be marketed in the US by Merck, is a biosimilar to Roche’s Herceptin.

It is indicated as an adjuvant therapy for HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

The drug can be used to treat patients who have not undergone any prior treatment for metastatic cancers.

Ontruzant is already available in many European markets, as it was approved by the European Commission in November 2017.

Samsung Bioepis senior vice-president and Commercial division head Sang-Jin Pak said: "For many cancer patients in the US, battling cancer has not only been a health issue, but a considerable financial burden brought on by cancer treatment.

"Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden. We sincerely hope our trastuzumab biosimilar will do exactly that."

Last month, the FDA approved Celltrion and Teva Pharmaceutical Industries’ Herceptin biosimilar called Herzuma for the treatment of HER2-overexpressing and metastatic breast cancer.

The regulatory approval was based on a review of foundational analytical similarity, non-clinical, clinical pharmacology, immunogenicity clinical efficacy and safety data.

Trial results showed no clinically meaningful differences in purity, potency and safety between Herzuma and Herceptin for treating patients with HER2-overexpressing breast cancer.

As part of an exclusive alliance formed in October 2016, Celltrion and Teva agreed to commercialise Herzuma in the US and Canada.

One of Roche’s blockbuster drugs, Herceptin generated around CHF7.01bn ($7.04bn) in sales in 2017, according to Reuters. The FDA rejected Pfizer’s Herceptin biosimilar in April last year.

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