Pamela N. Munster, MD, professor, department of medicine (hematology/oncology), University of California, San Francisco (UCSF), director, early phase clinical trials unit, co-leader, Center for BRCA Research, leader, Experimental Therapeutics Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses the developmental process for biosimilars in oncology.

As with biologics, there are requisites that biosimilars need to meet before they come to market, explains Munster. As long as data show that a biosimilar is equally as safe and effective as the originator drug, she would have no problem with prescribing a biosimilar, she adds.

To receive approval, a biosimilar has to undergo a rigorous set of tests as outlined by the FDA, says Munster, who adds that the path toward approval is not an easy one. As such, physicians can be fairly certain that a biosimilar has been thoroughly evaluated and has demonstrated similar safety and efficacy if approved, she concludes. In December 2018, CT-P6 (Herzuma; trastuzumab-pkrb) became the second trastuzumab biosimilar to be granted approval by the FDA.

Pamela N. Munster, MD

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Dr. Munster on Developing Biosimilars