Statement by Chip Davis, President and CEO, GPhA, Regarding Today's Congressional Hearing on BPCIA Implementation

Press Release

WASHINGTON, DC — The House Energy and Commerce Committee today held Congress’ first oversight hearing since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010.

“As the U.S. market for biosimilars takes shape, the future of these new medicines is dependent on policy decisions that promote patient access and competition,” said Chip Davis, President and CEO, Generic Pharmaceutical Association (GPhA). “Biosimilar manufacturers now have an approval pathway for safe and effective alternatives to costly brand biologic drugs. The first biosimilar has been approved under BPCIA and patients, payors and others are eager to see competition in the marketplace for biologics increase access and affordability.

The Biosimilars Council, a division of GPhA, is concerned that different international nonproprietary names for biologics and biosimilars could lead to patient and provider confusion, increasing the likelihood of prescribing errors and other unintended consequences.

The Council also urges the Centers for Medicare and Medicaid Services (CMS) to provide non-interchangeable biosimilars with a unique average sales price calculation and billing code, to ensure a competitive reimbursement. Additional clarity from currently outstanding FDA guidances on interchangeability, extrapolation and labeling are each critical to the timely availability of biosimilars in the United States. The Council urges the agency to issue these guidances promptly.

Pragmatic Congressional oversight can help ensure that the regulatory landscape supports the development of a robust marketplace for safe and effective biosimilars that enhances patient access and encourages these medicines to generate significant savings for millions of patients, payors and others who will rely on the savings they provide.”

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 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at www.gphaonline.org. Follow us on twitter: @gpha.

About the Biosimilars Council

The Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.