Teva, Celltrion Launch Fourth Trastuzumab Biosimilar

Teva Pharmaceuticals USA and Celltrion Healthcare have launched the fourth trastuzumab biosimilar, Herzuma, at a 10% discount to the cost of reference product Herceptin.

Three months after its FDA approval, a fourth trastuzumab biosimilar has been launched. Teva Pharmaceuticals USA and Celltrion Healthcare announced the market availability of Herzuma (trastuzumab-pkrb), an injectable biosimilar with the same indications as the Herceptin reference product.

The biosimilar arrival on market follows launches of other biosimilars for trastuzumab by Pfizer (Trazimera), Mylan/Biocon (Ogivri), Amgen/Allergan (Kanjinti). An additional trastuzumab biosimilar approved but not yet launched is Samsung Bioepis’ Ontruzant.

Herzuma is indicated for the treatment of breast cancer in the adjuvant setting, metastatic breast cancer, and metastatic gastric cancer.

The wholesale acquisition cost (WAC) for Herzuma 150 mg is $1402.50 and HERZUMA 420 mg is $3927, which is a 10% discount to the WAC of Herceptin, Teva and Celltrion said in a release. They said actual costs for Herzuma are expected to be lower because WAC does not account for rebates and further discounts that may apply.

“We are proud to make Herzuma available to patients in the United States living with HER2-positive breast and gastric cancers, and their providers,” said Brendan O’Grady, executive vice president, North America Commercial, Teva.

Teva and Celltrion also are partners on a biosimilar for rituximab, whose reference product is Rituxan. Teva and Celltrion’s version, Truxima, was approved November 28, 2018, and was launched in November 2019. The product also was being offered at a 10% discount to the list price of reference product. Truxima was made available at $845.55 for a 100-mg vial and $4227.75 for a 500-mg vial.

Although the reference rituximab also carries indications for inflammatory diseases including rheumatoid arthritis, Celltrion sought and received approval only for adults with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) either as monotherapy or in combination with chemotherapy.

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