Biosimilars policy should weigh patient safety, drug savings
In a recent opinion column in Forbes, Grace-Marie Turner, founder and president of the Galen Institute, a nonprofit public policy research organization, said biosimilar prescription pharmaceuticals can provide an avenue to keeping drug prices low.
Turner argues that state and federal lawmakers must advocate and pass policy that focuses on creating “sensible market-driven solutions” that place biosimilar drugs in the mainstream marketplace for pharmaceuticals.
She told Patient Daily in an interview that the only way to keep prices low is to allow for competition and to innovate delivery of such services, but there with some differences.
“Biosimilars are still going to be approved by the FDA to ensure that they still have the same basic functionality as original drugs,” Turner said. “But, because they are based on living organisms, there are going to be differences. Everyone is encouraging the development of biosimilars but there are some policy impediments.”
In the interview, Turner expounded on how risk factors associated with biosimilar drugs focus on two components: individual consumers and the manufacturers.
“To individuals, as long as their physician is making decisions based upon what he or she feels is the best drug for the patient, the risks (from biosimilars) to individuals is very low, if not negligible,” she said. “But, it is important because there are people who will not understand that biosimilars are not like generic or molecule drugs.”
Given basic differences in chemical compounds in medications, Turner pointed out that the medical community has the opportunity to determine which biosimilars work best in a competitive environment
Manufacturers, on the other hand, are faced with a series of regulatory barriers that could prevent an even playing field when biosimilars take on established, mainstream brand-name pharmaceuticals.
One of the other concerns that Turner brought up was the need for transparency in pricing for these medications among corporations, patients and providers. Ultimately, she argued, both in the interview and her op-ed, the most evident threat to a competitive environment in a prescription drug economic vertical will be influenced on how congressional lawmakers address certain provisions of fixed reference pricing – a rule passed under the Obama administration and enforced currently by the Centers for Medicare and Medicaid Services (CMS).
CMS is attempting to regulate biosimilars with price controls that were meant for traditional molecular pharmaceuticals which could potentially drive prices for Medicare recipients.
Organizations in this story
The Galen Institute P.O. Box 320010 Alexandria, VA 22320