FDA Commissioner Gottlieb Gives Speech on Biosimilars - Big Molecule Watch

Earlier today, FDA Commissioner Scott Gottlieb, MD, gave a speech focusing on biosimilars at America’s Health Insurance Plans’ National Health Policy Conference in Washington, D.C.  In his speech, Commissioner Gottlieb highlighted a 2017 study by QuintilesIMS that observed significant cost savings and dramatically expanding patient access in the EU from biosimilars competition.  He said the FDA will “help facilitate a robust market for these products,” but observed that market dynamics in the US seem to be hindering biosimilar competition.

Commissioner Gottlieb announced several initiatives to support the development of the biosimilars market in the United States.  First, he noted that FDA is examining a way to “better integrate policy and review functions that can provide greater scientific and regulatory clarity for sponsors, and greater efficiencies in the review of biosimilar and interchangeable applications.”  According to Commissioner Gottlieb, FDA is also developing information and tools to “support the conduct of smaller, targeted trials, and bring more biosimilars to market in a much more cost-effective and timely manner.”  To encourage adoption of biosimilars, FDA is “committed to educating clinicians and patients about the safety and effectiveness of FDA approved biosimilars.”  Finally, FDA intends to “strengthen partnerships with regulatory authorities in Europe, Japan, and Canada” in order to help harmonize requirements for approval and to create a global market for biosimilars.

According to Commissioner Gottlieb, there are two significant problems impacting biosimilars penetration in the US market:  rebating and contracting practices, and market consolidation.  “Too often,” he said, “we see situations where consolidated firms—the PBMs, the distributors, and the drug stores—team up with payors. They use their individual market power to effectively split some of the monopoly rents with large manufacturers and other intermediaries rather than passing on the saving garnered from competition to patients and employers.”  He went on to criticize the practice of reducing premiums with large co-pays or rebates because “sick people aren’t supposed to be subsidizing the healthy.  That’s exactly the opposite of what most people thought they were buying when the bought into the notion of having insurance.”

United Healthcare, the Commissioner noted, will be passing full drug rebates onto patients starting next year.  He called this a “potentially disruptive step” because “[t]his change could amount to hundreds, or even thousands of dollars in savings for patients, particularly those in high deductible health plans.”  He also called on payors to help the biosimilars market by making biosimilars the default option for newly diagnosed patients, waiving co-insurance, and lifting prior authorization requirements.

Big Molecule Watch will continue to follow regulatory developments that impact biosimilars, so check back for the latest news and analysis.


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