Statement by Ralph G. Neas, President and CEO, GPhA, Regarding the U.S. Market for Biosimilars

PRESS RELEASE

WASHINGTON DC (February 25, 2015) — “As the FDA considers the first biosimilars applications and payors begin to look at how to help make these new medicines available to their beneficiaries, it is in both the American patients’ and the U.S. health system’s interest to promote policies that foster a robust biosimilars industry. The release of The Economic Viability of a U.S. Biosimilars Industry, a new study authored by Matrix Global Advisors and sponsored by Prime Therapeutics, finds that federal, state and international regulatory decisions could have significant impact on the viability of biosimilar market entry.

As the study asserts, ‘It is essential for policymakers to understand the consequences of certain policy decisions on the development of a U.S. biosimilars market and to help create the market dynamics necessary for a biosimilars industry to thrive.’

One way the FDA could encourage these conditions is by adopting the existing International Nonproprietary Name (INN) conventions for biosimilars in the United States. Indeed, GPhA and more than 30 stakeholders representing pharmacies, labor unions, state retirement systems, and payors, arecalling for the FDA to require biosimilars and biologics to have the same INN, a practice already proven to be safe and effective for these medicines in Europe and other highly regulated markets.

GPhA is pleased to see the recent progress being made. In January, FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously to recommend that the agency approve filgrastim for each of the five indications in the biosimilar application.

Biosimilars are poised to dramatically impact patient care in the United States. That is why GPhA continues to collaborate with industry stakeholders and our regulatory and supply chain partners on international issues such as naming and exclusivity, federal regulatory issues such as interchangeability and extrapolation, and state-level issues relating to substitution. Together, we must ensure that the nascent biosimilars pathway in this country enables safe and timely patient access and patient savings for millions of people.”

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