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Alliance for Health Reform Hosts National Policy Briefing on Biosimilars Market
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The nonpartisan Alliance for Health Reform hosted a national policy briefing on the emerging biosimilars market. At the briefing, panelists discussed the future of biosimilars and what patients and physicians need to know.
According to the Associate Director for Therapeutic Biologics in the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, Leah Christl, PhD, two biosimilars have been approved by the FDA so far, but only one is available on the market. She noted that as of May 31, 2016, there were 60 proposed products in the Biosimilar Product Development program for the creation of biosimilar products to 19 different reference products.
“We think that it is important that the FDA stands behind these products and that we talk about our approval standards, and that folks understand what it is that we are looking at from a scientific perspective and find a way to communicate with the patient and prescribing community in a way that they understand what the standards are,” Christl said.
Angus B. Worthing
Angus B. Worthing, MD, FACR, FACP, of the American College of Rheumatology’s Government Affairs Committee, noted the importance of the regulatory efforts being enacted by the FDA to ensure the safety and efficacy of biosimilars for patients. According to a press release, he also highlighted concern regarding potential biosimilar substitution practices by pharmacists without prior notification, which could cause patients to become immune to both the biosimilar and biologic or cause allergic reactions. Cost was another focus, with Leigh Purvis, MPA, director of Health Service Research at AARP, noting an expected cost savings estimate with biosimilars of between 25% and 30% off the price of the biologic drug.
“It appears the biosimilars are being evaluated by the FDA in a way that should ensure safe, effective biosimilars and clear, transparent information in drug labeling,” Worthing told Healio.com/Rheumatology. “We hope that biosimilars will reduce cost and, therefore, improve access to treatments. The American College of Rheumatology will continue to work to prevent patients from being forced to switch between reference biologics and biosimilars.” – by Casey Tingle
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Disclosure: Worthing is a consultant for Abbvie Inc.