Teva and Celltrion Healthcare Launch Herzuma® (trastuzumab-pkrb) in the U.S. with 10% WAC Discount vs. Herceptin

Text | Fan Dongdong

Recently, Teva and Celltrion Healthcare jointly announced that their trastuzumab biosimilar, Herzuma, has been launched in the United States.

In 2015, the core patent for trastuzumab (Herceptin) expired in the United States, prompting generic drug manufacturers to take action. In December 2018, Herzuma, developed by Teva and Celltrion Healthcare, received approval from the U.S. FDA. Celltrion Healthcare and Teva entered into an exclusive partnership in October 2016, with Teva responsible for the commercialization of Herzuma in the United States and Canada.

Brendan O’Grady, Executive Vice President of Commercial Operations for Teva North America, stated, “We are honored to provide Herzuma to patients and healthcare institutions in the United States with HER2-positive breast cancer and gastric cancer. The launch of Herzuma underscores Teva’s commitment to helping reduce healthcare costs and enhancing price competition through the provision of biosimilars. As part of our long-term strategy, Teva will continue to invest in the biopharmaceutical sector and support patients worldwide.”

Hyoung-Ki Kim, Vice Chairman of Celltrion Healthcare, stated, “We are delighted that Herzuma has been launched in the United States. We look forward to continuing our collaboration with Teva to bring biosimilars to more patients. We believe that biosimilar products can address unmet needs in the market.”

In terms of pricing, the wholesale acquisition cost (WAC, or “list price”) for the 150 mg strength of Herzuma is $1,402.50, and for the 420 mg strength it is $3,927, representing a 10% discount compared to the WAC of Herceptin. In practice, however, because the WAC does not account for additional discounts and rebates that may apply, the actual out-of-pocket costs borne by patients and healthcare institutions using Herzuma will be lower than the WAC. Nevertheless, the specific amount of savings on out-of-pocket expenses will vary depending on the patient’s insurance coverage policies and eligibility for assistance programs.

In addition, Teva provides support services to specific patients through the CORE program. CORE is designed to assist eligible patients with the reimbursement process, facilitated by care coordinators and healthcare professionals.

It should be noted that Herzuma carries a boxed warning indicating that treatment with trastuzumab may be associated with cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.

In fact, two trastuzumab biosimilars had already entered the U.S. market prior to Herzuma. Kanjinti, the trastuzumab biosimilar developed by Amgen and Allergan, was approved in June 2019 and launched in the U.S. market in July of the same year. The two companies stated that Kanjinti’s wholesale acquisition cost was 15% lower than that of the reference product, with the 420 mg dosage priced at $3,697.26. In December 2019, Mylan and the Indian pharmaceutical company Biocon launched Ogivri, another trastuzumab biosimilar, in the United States. Although the specific price was not disclosed at the time, Mylan indicated that it would enter the market with a highly “competitive discount.”

With the addition of Herzuma, competition in this market has intensified once again!

Reference Source: Teva and Celltrion Healthcare Announce U.S. Availability of HERZUMA^® (trastuzumab-pkrb) for Injection