Tanja Obradovic: Herceptin biosimilar Hercessi has just been approved by FDA
Tanja Obradovic, Vice President of Oncology Scientific Affairs at ICON plc., shared a post on LinkedIn:
“Additional Herceptin biosimilar Hercessi (trastuzumab-strf) has just been approved by FDA on April 25th (link to FDA information).
It joins Herzuma (trastuzumab-pkrb), Ontruzant (trastuzumab-dttb), Trazimera (trastuzumab-qyyp) and Kanjinti (trastuzumab-anns). Hercessi is coming to US with quite a delay compared to other geographies. Since approval in the EU and China in July and August 2020, HLX02 (trade name: HANQUYOU in China, Hercessi in the U.S., Zercepac in Europe) it has been successfully approved and reimbursed in more than 40 countries and regions covering Asia, Europe, Latin America, North America, and Oceania.
As Hercessi gets launched and considering delay compared to other four Herceptin biosimilars already available in the US, it will be of interest to see where on the spectrum of reimbursement it will land. Very insightful article from last year reported that the biosimilars’ net prices ranged from 15% to 46% of Herceptin’s pre-competition net price. ”