The FDA has recently approved a biosimilar for the treatment of breast cancer. Trastuzumab-pkrb is a biosimilar with a similar mode of action as the already approved Trastuzumab. The biosimilar is a monoclonal antibody that has been indicated for the treatment of HER-2 positive breast cancer cells. Tumor cells will, hence, have to test positive for HER-2 marker before Trastuzumab-pkrb can be administered.
The drug, however, has several side-effects like infusion-related side effects, low WBC count, fatigue, nausea, diarrhea etc. It can also cause fetal-toxicity, pulmonary issues, and cardiomyopathy. The FDA, hence, suggests that patients receive a thorough cardiac check-up before the drug is administered. Source: Oncolink, University of Pennsylvania Clinical Oncology News