Last week’s Oncologic Drugs Advisory Committee recommendation that the FDA approve 2 biosimilar treatments brought Swiss drug maker Roche a step closer to inevitable competition from biosimilar treatments.
Last week’s Oncologic Drugs Advisory Committee (ODAC) recommendation that the FDA approve 2 biosimilar treatments brought Swiss drug maker Roche a step closer to inevitable competition from biosimilar treatments.
ODAC voted unanimously to recommend the approval of Amgen’s biosimilar bevacizumab candidate ABP 215 (referenced on Roche’s Avastin) and MYL-1401O, Mylan and Biocon’s biosimilar trastuzumab candidate (referenced on Roche’s Herceptin). The drugs are widely expected to be approved by the FDA in September.
While the slow pace of litigation surrounding biosimilar drugs in the United States suggests that Roche will not face an immediate threat to its US market share for bevacizumab and trastuzumab, Tim Race, analyst for Deutsche Bank, told The New York Times that "Roche has $22 billion of revenues exposed” to biosimilar products now making their way to the marketplace.
Roche has long maintained that it will be able to keep its sales dominance through the development of novel treatments, and some forecasts suggest that the drug maker’s pertuzumab (Perjeta), a monoclonal antibody used in first-line therapy for HER2-positive metastatic breast cancer, in combination with trastuzumab and docetaxel, could help the company to do just that. Because pertuzumab would extend the duration of treatment, it would contribute to greater sales over time, and its joint use with trastuzumab could help to protect sales of Roche’s innovator Herceptin.
However, Roche’s recent setback with its immunotherapy treatment atezolizumab (Tecentriq) has raised concerns that the company’s innovative drugs may not be enough to retain its foothold in the oncology market. In April, atezolizumab was granted accelerated approval as an initial treatment for patients with locally advanced or metastatic urothelial carcinoma. However, in May, the drug did not meet the primary endpoint of improving overall survival in the second-line setting in a phase 3 trial. Roche has since announced positive data from phase 1, 2, and 3 studies suggesting that the drug could be used in combination with other treatments across a range of other cancers, but the failure of the drug to perform in the treatment of bladder cancer came as a blow to Roche.
Other novel drugs in Roche’s pipeline are 2 drugs for the treatment of Alzheimer’s disease: crenezumab and gantenerumab. The drugs, both of which are in phase 3 development, could jointly reach $130 million in sales by 2022 if approved. Also in Roche’s late-stage pipeline are lampalizumab, indicated to treat dry age-related macular degeneration; etrolizumab, indicated for ulcerative colitis and Crohn’s disease; and emicizumab, indicated in hemophilia A.