PCMA, NCPA blast biosimilars legislation

Some biotech drug manufacturers are lobbying state legislators to restrict access to biosimilar versions of costly brand medications, according to the Pharmaceutical Care Management Association (PCMA) and National Community Pharmacists Association (NCPA).

“Biotech companies are in the process of erecting as many barriers as they can to pharmacists interchanging biosimilars because they know how effective community pharmacies are at lowering costs through the substitution of lower-cost generic medications,” said John Norton, public relations director for NCPA.

"Campaigning to restrict the use of biosimilars enriches brand manufacturers at the expense of the employers, public health programs, and patients who need access to lower-cost medicines," said PCMA President and CEO Mark Merritt.

In fact, the Virginia House of Delegates recently passed a bill restricting pharmacists from substituting generic versions of biologic drugs for brand-name products. Virginia H.B. 1422 “limits automatic substitution of biologics to those deemed interchangeable by FDA and requires physician notification in a reasonable time frame following substitution,” according to SafeBiologics.

In addition, legislation restricting biosimilars is pending in nine states: Arkansas, Colorado, Florida, Indiana, Massachusetts, Mississippi, North Dakota, Texas, and Washington. “While we need to assess state bills on a case-by-case basis as the details may differ among them, we support pharmacists’ ability to automatically substitute biosimilar interchangeable products that are approved by FDA for interchangeable use,” Norton said.

As part of the Affordable Care Act, the FDA is in the process of developing a pathway for approval of biosimilars and determining interchangeability for the new products. However, drug manufacturers’ lobbying efforts are designed to “preempt the FDA's process by creating a flurry of state laws that will conflict with the FDA's forthcoming national standards,” according to a statement from PCMA.

“Creating a patchwork of dueling state and federal rules would make it harder for pharmacists to know when they can dispense a biosimilar. That would raise costs for patients and their employers, who typically cover two-thirds of prescription drug benefit costs,” the PCMA statement said.