January 31, 2013


(Washington, DC)— Some biotech drug manufacturers are lobbying state legislators to restrict access to biosimilar (or biogeneric) versions of expensive brand medications, the Pharmaceutical Care Management Association (PCMA) said today. Such proposals would increase costs for employers, public health programs, and patients, and restrict access to lower cost alternatives.

A recent New York Times article uncovered the campaign, which seeks to protect expensive biologic rheumatoid arthritis, psoriasis, and cancer treatments from generic (biosimilar) competition. Many of the brand versions of these medicines cost “tens or even hundreds of thousands of dollars a year.”

A pathway for the Food and Drug Administration (FDA) to approve generic versions of biologic products was passed in the Affordable Care Act. Currently, the FDA is in the process of developing this pathway for approval of biosimilars and determining “interchangeability” for the new products.

This campaign is designed to preempt the FDA’s process by creating a flurry of state laws that will conflict with the FDA’s forthcoming national standards. 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.

“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.

Legislation is currently pending in 10 states including Arkansas, Colorado, Florida, Indiana, Massachusetts, Mississippi, North Dakota, Texas, Virginia, and Washington.