Statement by Ralph G. Neas, President and CEO, GPhA, Regarding FDA Approval of the First Biosimilar Medicine in the US

PRESS RELEASE

Washington, DC (March 6, 2015) —

“Today’s FDA approval of Zarxio (filgrastim-sndz), the first biosimilar medicine in the United States, heralds a new era for cancer patients and the American health care system, one where access to safe, affordable versions of lifesaving biologics will finally be a reality. Consumers, employers, private insurers, taxpayers, state governments and federal programs all will benefit from the advent of biosimilars, as intended by the Biologics Price Competition and Innovation Act (BPCIA) that was enacted as part of the Affordable Care Act.

The FDA’s approval of Sandoz’s Zarxio (filgrastim-sndz) indicates that the Agency has scientifically determined that the medicine is “highly similar” to, and has “no clinically meaningful differences” from, the reference product, so that cancer patients in the United States can now rely on the same biosimilar that has been available in Europe for years. Several GPhA member companies have developed, manufactured and are marketing biosimilars around the globe, and there are four other known applications accepted for Agency review at this time.

Dozens of organizations representing consumers, seniors, payers, pharmacists, purchasers, pharmacy benefit managers, labor unions, retail pharmacies, managed care pharmacies and other health care stakeholders have long-anticipated this moment. It is deeply gratifying to have our collaborative efforts to educate policymakers and promote access, affordability and competition in the biologics sector, realized today. We congratulate the Agency, Sandoz and most importantly, patients on this historic development.

As the FDA continues its work to implement the BPCIA, we reiterate our stance that the Agency’s departure from the currently accepted international nonproprietary name (INN) system could disrupt the ability to track and dispense these medicines, risking provider confusion and patient safety. GPhA andmore than 30 health organizations agree that it is critical to preserve the system already proven to be safe and effective worldwide.”

About GPhA

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 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha