US Market Is Still Waiting for Biosimilars to Produce Meaningful Price Reductions

Natalie Pompilio
Published: Thursday, Mar 14, 2019
Gary H. Lyman, MD, MPH

Gary H. Lyman, MD, MPH
When the FDA approved its first biosimilar drug in 20151—filgrastim-sndz (Zarxio), for compromised white blood cell count—there was talk of the benefits of competition in the pharma industry; increased access to medications for patients; and, of course, the all-around savings. After all, the cost of developing and guiding a biosimilar through the approval process is a fraction of the cost of developing a reference biologic: in the range of 0 million to 0 million versus .6 billion for a new prescription medicine.2,3

“I’m a practicing oncologist, and some of us have used [originator biologics] for 10, 15, 20 years, and we’ve gotten very comfortable with them,” Lyman said. Given the very nature of biologics— the complex manufacturing involved and the difficulty of preparing identical batches of drugs— it is doubtful that parallelism of quality between biosimilars and biologics can be maintained over the long haul, Lyman said: “I would argue that all biologics are prone to drift with changes in conditions, and studies have shown original biologics on the shelf today are not the same as they were 15 years ago. The originator drugs we’ve gotten really comfortable with are really biosimilars to the ones we started using years ago.”

Opposition to Biosimilars

Biologics have led to breakthroughs in oncology and other serious diseases, and they typically cost tens of thousands of dollars for a year of treatment, and with this amount of money at stake, manufacturers of original biologics are suspected of deliberately trying to thwart the introduction of lower-cost biologics, according to a news report earlier this year. Outgoing FDA Commissioner Scott Gottlieb, MD was quoted expressing concerns about “deliberate or unintentional efforts by branded companies to create confusion” about the safety and effectiveness of biosimilars, which the FDA examines for reliability and efficacy as part of marketing approval.11
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