Statement by Ralph G. Neas, President and CEO, Generic Pharmaceutical Association, on FDA’s Acceptance of Sandoz Biologics License Application for Filgrastim Under the New Biosimilar Pathway
“For the first time, the FDA has accepted a filing for an approval of a biosimilar drug, a major step toward access for Americans to safe, effective alternatives to costly brand biologic medicines.
Biosimilars have been successfully used in Europe and other markets for years. Filgrastim’s filing acceptance moves us closer to the day when U.S. patients that currently must rely on costly brand biologics for treatment will have more choices for the medicine that they need.
This approval represents a new frontier — not only for patients, but for our nation’s health system. Express Scripts projects that the United States would save $250 billion between 2014 and 2024 if filgrastim and 10 other biosimilars would enter the market.
We look forward to the integration of biosimilar therapies into the American health system, and witnessing the realization of the transformative potential of these innovative therapies.”
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 84 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Generics saved saving the U. S. health system $217 billion in 2012 alone. Additional information is available at www.gphaonline.org. Follow us on twitter: @gpha.