The FDA recently approved a trastuzumab biosimilar, Hercessi (trastuzumab-strf; HLX02) from Accord BioPharma, to reference product Herceptin, for the treatment of several forms of HER2-positive breast and gastric cancers. Hercessi is supplied in powder form for reconstitution prior to infusion.
Hercessi is the sixth trastuzumab biosimilar approval overall.
Hercessi was granted interchangeable designation.
Prior biosimilars to trastuzumab are as follows—-
- Ogivri (trastuzumab-dkst) December 2017
- Herzuma (trastuzumab-pkrb) December 2018
- Ontruzant (trastuzumab-dttb) January 2019
- Trazimera (trastuzumab-qyyp) March 2019
- Kanjinti (trastuzumab-anns) June 2019
HER2-positive, is an aggressive form of cancer in which cancer cells grow rapidly. However, HER2-positive breast cancer generally responds well to treatment.
Breast cancer is the most common cancer in women in the U.S., and HER2-positive breast cancer accounts for about 20 percent of all breast cancer diagnoses (in 2023, that’s 297,790 women and 2,800 men who will be diagnosed).
Pricing for Hercessi has not been confirmed.
The company has not disclosed plans for distribution.
CLICK HERE to access prescribing information
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