GPhA responds to Congressional hearing on BCPIA

WASHINGTON — The House Energy and Commerce Committee convened Thursday to hold an oversight meeting about the Biologics Price Competition and Innovation Act of 2010, the first since President Barack Obama signed the legislation paving the way for biosimilars in 2010. 

 

Among the stakeholders in the enactment of the law is the Generic Pharmaceutical Association’s Biosimilars Council, whose members include companies that have developed or are developing biosimilar drugs. GPhA president and CEO Chip Davis commented on the hearings, noting the need for more straightforward naming conventions for biologics and biosimilars and calling for price calculations that ensure sufficient reimbursement from the Centers for Medicare and Medicaid Services (CMS). 

 

“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,” David said. “The Council also urges [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.”