- South Korean biosimilar specialist Samsung Bioepis received approval from the Food and Drug Administration for its first U.S. oncology biosimilar, Ontruzant, the company announced Sunday.
- A copycat of Roche's Herceptin, Ontruzant has the go-ahead across all eligible indications, and will be distributed by partner Merck & Co in the U.S.
- Ontruzant is the third Herceptin biosimilar to be approved in the U.S. No launch date has been confirmed as yet.
Composition of matter patents on Herceptin (trastuzumab) have already expired in Europe, clearing the way for biosimilar, including Ontruzant (trastuzumab-dttb), to launch.
The U.S. market hasn't been as robust for biosimilars as its European counterpart, however. Herceptin's U.S. patent is due to expire in mid-June, and while the FDA has approved three biosimilars — Ontruzant, Celltrion and Teva Pharmaceutical's Herzuma and Mylan's Ogivri — none have launched yet.
Internationally, Herception competition has been more robust. Ontruzant was the first Herceptin biosimilar to be approved in Europe in November 2017, and since then, it has been joined by a number of others. In Japan, Daiichi Sankyo launched a Herceptin copycat in November 2018, and other biosimilars are on their way.
The impact from this competition is evident on Roche's bottom line. Through the first nine months of 2018, European and Japanese sales of Herceptin dropped 12% and 16% respectively, while U.S. sales were up 12%. Herceptin remained Roche's top-selling drug in this period, ahead of Rituxan (rituximab) and Avastin (bevacizumab), both of which are also up against biosimilar competition.
Credit Suisse predicts a 21% erosion in Herceptin sales in 2019, with up to five approved biosimilars, and erosion of around 50% by 2022.
On a recent earnings call, Daniel O'Day, then head of Roche's pharmaceuticals division, dismissed the idea that the sales erosion would be as much in the U.S. as in Europe, saying that he believed the heterogenous nature of the U.S. healthcare system would limit the uptake.
Despite the company's confidence, however, a worst-case scenario on its top three biologics could leave a $10 billion revenue hole by 2022.