Experts From BIO, PhRMA Deliver Policy and Legislative Updates on Biosimilars

At the American Conference Institute (ACI)’s Summit on Biosimilars meeting, held June 25-27 in New York, New York, panelists Crystal Kuntz, vice president of healthcare policy and research at Biotechnology Innovation Organization, and David Korn, vice president of intellectual property and law at Pharmaceutical Research and Manufacturers of America provided an overview of recent policy and legislative updates in regard to biosimilars.

The panelists opened up the discussion by reviewing legislative updates to the space that have taken place in the last year. According to Korn, although not directly focused on biosimilars, the passage of the FDA Reauthorization Act in August 2017 was the most significant development, as “The [legislation] covers everything from fees relating to drugs, and devices.”

Building upon the Biosimilar User Fee Act that was signed into law in 2012, the FDARA clarified some of the fee structures listed within the document and included some commitments from the FDA in regard to the review process for biosimilars. Specifically, the law states that the FDA is committed to reviewing 90% of first time biosimilar applications as well as resubmissions that it receives within 10 months of the 60-day filing date.

In addition, Kuntz discussed recent proposals made by the Trump Administration, where “a lot of the rhetoric we’ve been hearing boils down to the administration saying that ‘someone needs to do something about drug pricing.’”

Kuntz noted that although the release of Trump’s blueprint to address the cost of drugs in May was a good start, “the document is very broad, and hints at things the administration would like to achieve but contains no specific policy proposals.”

In summarizing action taken by various government departments in the past year, Kuntz presented on CMS’ move to lower cost-sharing for biosimilars, as well as the reversal of another CMS decision that now allows for each biosimilars to receive its own J code tied to billing through the Medicare program.

As for the future, panelists agreed that they are keeping an eye on the proposed Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, and the potential for movement on the Affordable and Safe Prescription Drug Importation Act that was introduced in Congress February 2017. Although decision on the Act is still pending, it could have a potential impact on biologics. In addition, both noted the importance of future developments tied to the blueprint to reduce drug pricing, and they expect to see more proposals from CMS that potentially allow health plans to have more flexibility in the drugs they cover.