Lessons from the European Experience with Biosimilars
Custom Synthesis, A theme of the AACR panel discussion was the need to educate clinicians and patients about biosimilar products, including what they are and how they are approved.
FDA has developed educational materials on biosimilars for patients and prescribers, as well as for nurses who will administer biosimilars and pharmacists who will dispense them. The agency intends to provide health care professionals with the information they need to consider prescribing these drugs as they become available, FDA Commissioner Scott Gottlieb, M.D., has said.
Thirty biosimilars have been approved in Europe since 2006, and these agents have helped to “lower costs and increase patient access to biologics,” the President’s Cancer Panel noted in its report. The report highlighted a study on the use of biosimilars in Europe, which raised no concerns about the safety or effectiveness of these treatments.
“The fact that biosimilars have been used in Europe and in Japan should give us some assurance that the drugs are as safe and effective as the corresponding reference products,” said Chadi Nabhan, M.D., M.B.A., the chief medical officer at Cardinal Health Specialty Solutions, who conducted a survey of oncologists about their perceptions and acceptance of biosimilars.
“It’s important to explain to clinicians and to patients that the FDA uses rigorous methods to approve biosimilars,” continued Dr. Nabhan. “Many oncologists don’t know how biosimilars get approved, but education can help address this gap in knowledge.”
In the survey, many oncologists responded that once a biosimilar has been approved, they would be as comfortable prescribing it as they would a reference treatment—regardless of the patient’s stage of disease and the goal of therapy, Dr. Nabhan explained.
“A lack of familiarity with—and concerns about—the concept of extrapolation also emerged in the survey as a barrier to adoption of biosimilars,” he added.
Many More Biosimilars in the Pipeline
The favorable perceptions of clinicians toward biosimilars “are a critical first step” toward the adoption of these medicines, Dr. Nabhan concluded. But with so few FDA-approved biosimilars for cancer, it’s too soon to know what impact biosimilars will have in the United States, including whether they will ultimately lead to lower costs for cancer care, he added.
That could change.
“As patents and exclusivity protections for biologics continue to expire in the US, we can expect many more biosimilars to be submitted for approval, creating greater competition within the marketplace,” said Dr. Christl.
More products on the market “will influence uptake the most,” she noted.
“Biosimilars,” Dr. Nabhan added, “are here to stay. As more biosimilars come on the market, we can begin to assess the potential impact on health care costs.”http://www.haihengpharma.com/lessons-from-the-european-experience-with-biosimilars/News