- The Food and Drug Administration has accepted two new filings for drugs that mirror Roche's Herceptin, potentially expanding the list of therapies capable of taking away market share from the blockbuster biologic.
- Amgen and Allergan plc's ABP 980 and Celltrion Inc.'s CT-P6 are now under review, according to separate statements issued Monday. They follow Mylan and Biocon's Herceptin biosimilar, MYL-1401O, which the FDA accepted for review almost seven months ago.
- Roche, however, has been preparing for competition from biosimilars for quite some time. New drugs are a particular focus. Not only did they help raise the company's pharmaceutical sales 3% last year, but the Swiss drugmaker has also been pairing them with older offerings such as Herceptin to extend life cycles.
Though more competitors are now circling the Herceptin (trastuzumab) franchise, Roche is confident in its ability to wade biosimilar waters — and rightfully so.
Last year, the company saw an unprecedented level of new drug approvals. What's more, it has been working on a subcutaneous form of the breast cancer drug, as well as combination treatments with another one of its oncology offerings, Perjeta (pertuzumab).
"We're still in the early stages of that development program," Daniel O'Day, CEO of Roche Pharmaceuticals, said of the Herceptin/Perjeta combo during the company's recent second quarter earnings call. "But I remind you that we've got obviously Perjeta in the entirety of its programs, rolling out in the United States and elsewhere. We've got Herceptin [subcutaneous] which is up now to around 50% in the launched countries."
"So I think we've got a variety of programs that allow us to continue to compete ... against the biosimilars," O'Day added.
Part of the reason Roche may be so prepared is that copycat versions of Herceptin have long been anticipated. In March, the Swiss drugmaker settled with Mylan, giving the latter company a global license for the trastuzumab product franchise.
Roche said in its second quarter earnings call that it expects Herceptin biosimilars in the U.S. market by early 2018 or sooner.
Yet in spite of the growing threats, Herceptin remains immensely profitable. The drug brought in CHF 3.54 billion ($3.58 billion) during the front half of 2017 alone, up 3% under a constant exchange rate from the same period a year prior.
Roche's two other blockbuster biologics, Avastin (bevacizumab) and Rituxan (rituximab), also face looming biosimilar competition in the U.S. and in Europe, where a copy of Rituxan won approval in June.