Healthcare Stakeholders Call On FDA to Support Patient Access to Biosimilars by Avoiding Unnecessary Labeling Statements

To ensure patient access to newer, more affordable versions of biologic medicines, the Food and Drug Administration should avoid requiring a statement of biosimilarity on the product label, a group of leading pharmaceutical supply chain organizations stated in a letter submitted to the agency today

PRESS RELEASE

WASHINGTON, DC (June 3, 2016) — To ensure patient access to newer, more affordable versions of biologic medicines, the Food and Drug Administration (FDA) should avoid requiring a statement of biosimilarity on the product label, a group of leading pharmaceutical supply chain organizations stated in a letter submitted to the agency today. The 11 signatories support biosimilar labeling that will lead to the increased access and cost-saving promise of biosimilars, also articulated in the Generic Pharmaceutical Association (GPhA) and its Biosimilars Council’s comments submitted to FDA.

“We applaud the agency’s efforts to educate providers about biosimilars. However, a statement of biosimilarity on the label is unnecessary and could put biosimilar utilization and savings at risk,” said Chip Davis, President and CEO, GPhA. “To date, we are not aware that FDA has provided sufficient justification for its inclusion in biosimilar labeling. Unwarranted differentiation between biosimilars and their reference products can undermine provider and patient education efforts as biosimilar products become available for the first time to millions of U.S. patients.”

The letter’s 11 signatories include: Academy of Managed Care Pharmacy (AMCP), America’s Health Insurance Plans (AHIP), American Pharmacists Association (APhA), Blue Cross Blue Shield Association (BCBSA), CVS Health, Express Scripts, Healthcare Supply Chain Association (HSCA),

Pharmaceutical Care Management Association (PCMA), Premier healthcare alliance, Prime Therapeutics and UAW Retiree Medical Benefits.

The letter states:

In most cases, the scientific information necessary to approve a biosimilar will primarily focus on establishing biosimilarity between the two products. This means that safety and efficacy information will come from studies of the reference product rather than the biosimilar. Including a biosimilar product’s biosimilarity data in addition to that of the reference product would only provide unnecessary information and create confusion for prescribers and patients.

This differentiation between biosimilars and their reference products risks undermining the important provider education that is being done by the FDA today. Informing providers that “biosimilars have no clinically meaningful differences in terms of safety, purity and potency (safety and effectiveness) from the reference product” while requiring a differentiator on the labeling sends mixed signals to providers responsible for driving patient familiarity and comfort with these products.