“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," Davis said.
GPhA represents the generic pharmaceutical industry, an industry that accounts for 88 percent of the prescriptions filled in the U.S.
“Biosimilar manufacturers now have an approval pathway for safe and effective alternatives to costly brand biologic drugs,” Davis said.
The Biosimilars Council, a division of GPhA, works as a leading source of information and education about the safety and effectiveness of generic drugs, and also works to make sure individuals can have access to medicines that are equally as effective but less costly than their branded counterparts.
At the hearing, the council called for the Centers for Medicare and Medicaid Services (CMS) to give biosimilars a unique average sales price calculation and billing code in order to allow for a competitive reimbursement.
The council also called for more clarity on outstanding FDA guidances on interchangeability, extrapolation and labeling, which can slow the process of pharmaceutical companies being able to put their biosimilar on the market and allow for individuals to have access to it.
“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,” Davis said.
Alerts Sign-up