Herzuma, Biosimilar to Herceptin, Available in US for HER2-positive Breast Cancers

Herzuma, Biosimilar to Herceptin, Available in US for HER2-positive Breast Cancers
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 struct
Subscribe or to access all post and page content.