Herzuma, a biosimilar to Genentech‘s Herceptin (trastuzumab), is now available in the U.S. for the same indications as the reference therapy, including for the treatment of HER2-positive breast cancers and stomach cancers.
The treatment was approved by the U.S. Food and Drug Administration (FDA) in December 2018, the same year it was approved by the European Medicines Agency.
“We are proud to make Herzuma available to patients in the U.S. living with HER2-positive breast and gastric cancers, and their providers,” Brendan O’Grady, executive vice president of North America commercial at Teva, said in a press release.
Herzuma is a Herceptin biosimilar developed by Teva Pharmaceuticals and Celltrion Healthcare. Biosimilars are medical products that are nearly identical to approved therapies, but are manufactured by a different company after the patent for the original therapy expires. Such medications are usually available at lower costs.
Herzuma is an antibody that, like Herceptin, targets the HER2 molecule in cancer cells, which is produced at high levels in up to 30% of breast and stomach cancers. When bound to HER2, the treatment triggers the death of cancer cells directly, by stopping key signals for cancer cell growth and survival, and by recruiting immune cells to the cancer’s vicinity.
The effects of biological molecules manufactured in cells, which is the case in Herceptin and Herzuma, are more difficult to replicate than those of artificial chemical compounds. Therefore, companies must show data proving that a candidate biosimilar has safety and efficacy profiles similar to those of the original compound before they are approved.
The approvals were based on extensive comparisons between Herzuma and its original product, in their structure, function, how they behave in the body (pharmacokinetics), how the body is affected by them (pharmacodynamics), as well as their safety and efficacy data.
In a prior Phase 3 trial (NCT02162667), researchers showed that Herzuma had a similar efficacy and safety as Herceptin in HER2-positive early-stage breast cancer patients.
The trial included 549 patients who were randomly assigned Herzuma or Herceptin as neoadjuvant (before surgery) and adjuvant (after surgery) treatment for one year.
The main goal was to determine if the rates of patients achieving a pathological complete response (no signs of cancer under the microscope in tissue samples removed during surgery) were comparable between treatments. Secondary measures included overall response rate, pharmacokinetics, pharmacodynamics, and safety.
The study showed that a pathological complete response was achieved by 46.8% of patients on Herzuma and 50.4% of patients on Herceptin. All other secondary endpoints were also met.
The treatment is now available for multiple breast cancer indications. For patients with early-stage breast cancer, it is approved as a post-surgery treatment regimen, either alone following anthracycline-based therapy, or as part of a combo treatment with chemotherapy agents.
For metastatic breast cancer, Herzuma is approved as a single agent for patients who received prior treatment for their metastatic disease, or as a first-line therapy in combination with paclitaxel.
Patients are selected for treatment with Herzuma based on an FDA-approved test.
“The launch of Herzuma continues our commitment to help lower healthcare costs and increase price competition through the availability of biosimilars,” O’Grady said. “Teva is continuing to invest in biopharmaceuticals as part of our long-term strategy for the future, and to help patients around the world, and we look forward to additional milestones for our biosimilar products later this year.”
The list price for Herzuma is $1,402.50 for a 150 mg vial and $3,927 for a 420 mg vial, a 10% discount compared to Herceptin. But the company says that actual costs to patients and providers will likely be lower, as the list price does not take into account any discounts, allowances, or other price concessions.
Patients eligible for Herzuma may find patient support services at Teva’s CORE assistance program, which helps them navigate the complex process of treatment coverage and reimbursement.
“We are pleased that Herzuma is now available to patients in the U.S.,” said Hyoung-Ki Kim, vice chairman at Celltrion Healthcare. “We look forward to continuing our partnership with Teva to bring biosimilars to as many patients as possible in the U.S., as we believe they address an unmet need in the market.”