Andrea De Censi, MD, director of the medical oncology unit at the National Hospital E.O. Ospedali Galliera—SC Oncologia Medica in Genoa, Italy, discusses the hope for biosimilars in the United States.

De Censi hopes that the United States adopts a similar stance on biosimilars as Europe. In Europe, biosimilars are used on a daily basis in clinical practice. These products work very well, says De Censi, and they have helped put constraints on the rising cost of healthcare. The development of these agents helps to ensure that healthcare is sustainable.

Notably, Europe is approximately 10 years ahead of the United States when it comes to the development and introduction of biosimilars into routine clinical practice. As such, it may take some time before the true impact of biosimilars is felt in the marketplace. Although biosimilars for granulocyte colony-stimulating factor were approved in 2015, it was not until 2017 that the FDA approved bevacizumab-awwb (Mvasi), a biosimilar to bevacizumab (Avastin). This was the first biosimilar to receive regulatory approval for cancer treatment in the United States. Several biosimilars have followed suit, including those for rituximab (Rituxan) and trastuzumab (Herceptin).

Videos

Andrea De Censi, MD, director of the medical oncology unit at the National Hospital E.O. Ospedali Galliera–SC Oncologia Medica in Genoa, Italy, discusses the hope for biosimilars in the United States.

Dr. De Censi on the Hope for Biosimilars in the United States

Andrea De Censi, MD, director of the medical oncology unit at the National Hospital E.O. Ospedali Galliera—SC Oncologia Medica in Genoa, Italy, discusses the results of the phase III TAM-01 trial in breast cancer.

This trial randomized 500 women with operated hormone sensitive breast ductal or lobular carcinoma in situ to receive either low-dose tamoxifen or placebo to assess the potential recurrence risk reduction. After a median follow-up of 5 years, results showed a 52% reduction in the risk of recurrence with low-dose tamoxifen compared with placebo, says De Censi, meeting the criteria for statistical significance.

Moreover, there were 14 (5.5%) events of disease recurrence in the tamoxifen arm versus 28 (11.3%) in the placebo arm (HR, 0.48; 95% CI, 0.26-0.92; 

 = .024). The number of events has been relatively low, he adds. More follow-up is needed to assess the benefit of low-dose tamoxifen in this patient population.

Andrea De Censi, MD, director of the medical oncology unit at the National Hospital E.O. Ospedali Galliera–SC Oncologia Medica in Genoa, Italy, discusses the results of the phase III TAM-01 trial in breast cancer.

Dr. De Censi Discusses the Results of the Phase III TAM-01 Trial in Breast Cancer

Andrea De Censi, MD, director of the medical oncology unit at the National Hospital E.O. Ospedali Galliera—SC Oncologia Medica in Genoa, Italy, discusses the financial benefit of biosimilars in oncology.

Because several patents for reference products expired a few years before those in the United States, biosimilars have hit the market much quicker in Europe. De Censi says he is very much in favor of biosimilars, which he believes are “the way forward” in the space. Treatment is rapidly advancing in multiple tumor types, but the rising price of new oncologics is not sustainable.

The only entity benefitting from high drug cost is the pharmaceutical industry, he adds. Some patients cannot access potentially life-saving therapy because insurance companies cannot afford these treatments. Part of the responsibility falls on community oncologists, De Censi says, because there is not enough dialogue between physicians and manufacturers.

Andrea De Censi, MD, director of the medical oncology unit at the National Hospital E.O. Ospedali Galliera–SC Oncologia Medica in Genoa, Italy, discusses the financial benefit of biosimilars in oncology.

Andrea De Censi, MD

Articles

Dr. De Censi on the Hope for Biosimilars in the United States

Dr. De Censi Discusses the Results of the Phase III TAM-01 Trial in Breast Cancer

Dr. De Censi Discusses Financial Benefit of Biosimilars