With a dozen approvals for biosimilars under its belt already, the Food and Drug Administration has started a new effort to accelerate the development and adoption of the drugs.
The agency announced last week its Biosimilars Action Plan, or BAP. According to the agency, the program is focused on improving the efficiency of the biosimilar and interchangeable product development and approval process; maximizing scientific and regulatory clarity for developers; developing communications to promote understanding of the products among patients, doctors and payers; and reducing what it calls gaming of FDA requirements and other attempts to delay competition in order to support market competition. The Biologics Price Competition and Innovation Act, which was passed in 2010 as part of the Affordable Care Act, established an abbreviated approval pathway for biosimilars.
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Under FDA regulations, biosimilar manufacturers have to provide additional information to the agency showing that their product can be expected to produce the same clinical result in any given patient in order to be considered interchangeable with the original branded product, hence the aforementioned phrasing appearing throughout the BAP. German drugmaker Boehringer Ingelheim is running a 240-patient Phase III clinical trial of Cyltezo – a biosimilar of AbbVie’s autoimmune disease drug Humira (adalimumab) – designed to show interchangeability between the two that enrolled its first patient last July. However, while Cyltezo received FDA approval in August, the agency has yet to approve any biosimilars as interchangeable despite thus far approving 12 biosimilars overall. Cyltezo’s approval followed the agency’s September 2016 green light for another biosimilar of Humira, Amgen’s Amjevita.
Actions that the FDA is taking under the BAP include creating new agency review tools like standardized review templates tailored to biosimilars; creating information resources and development tools for drugmakers like in silico models and simulations; including more information about approved biologics in the Purple Book and several others. The Purple Book lists approved biologics and their patent information. It is similar to the Orange Book, an online database that contains corresponding information for pharmaceutical products.
While drugs in a number of therapeutic classes have grown in price in recent years, biologics have led spending growth. According to an analysis from October 2017 by the RAND Corp., introducing biosimilars could cut health care spending by $54 billion over the next decade. While 1-2 percent of the population is treated with biologics each year, the drugs accounted for 38 percent of prescription drug spending in 2015 and for 70 percent of prescription drug spending growth between 2010 and 2015.
Photo: Dmitrii_Guzhanin, Getty Images
