Gottlieb: FDA Considering an End to Biosimilar Bridging Studies

Scott Gottlieb, MD, Commissioner of the FDA, is calling for changes to biosimilar regulation to help facilitate biosimilar approval, market entry, and competition.

In an interview with Kaiser Health News yesterday, Gottlieb said that the FDA is exploring whether to do away with bridging studies used in biosimilar development, echoing the argument of a paper published last year in BioDrugs. This change would allow developers to purchase the drugs they need to demonstrate biosimilarity directly from Europe without further demonstrating that the European-licensed and US-licensed reference products are similar.

“I have lawyers now looking at this,” said Gottlieb. The FDA has been exploring the issue for a few months, he said, and notes that it may be “…hard for us to get there without legislation, but we’re not done yet looking at this; we’re still pressing on this.”

Gottlieb said he will do everything “within my lane” to combat high drug prices, and that he sees drug companies “gaming the system to try to block competition” in many ways within the current marketplace. Last fall, Gottlieb said he wanted to “end the shenanigans” that interfere with competition in the marketplace. Since then, the FDA has announced a new action plan on biosimilars. “All of these steps are going to have an impact, and I don’t think there’s [1] silver bullet. If anyone [thinks] there is one thing you can do with policy intervention that is going to dramatically change drug prices, that’s not true. [There are] layers of things that we can do to try to make sure the system is working,” said Gottlieb.

Separately, Gottlieb and the FDA issued a statement that voiced support for the White House’s budget proposal, released last week, and its potential impact on the FDA. President Trump’s proposal seeks $3.3 billion for the FDA, which is an increase of more than $460 million from 2017. Including the cost to companies for drugs or devices submitted to the FDA for review, the agency’s budget escalates to $5.8 billion.

“New scientific opportunities, as well as advances in manufacturing and commerce, give the FDA new ways to advance our mission to protect and promote public health...Investing in these initiatives will help the FDA advance goals that we all share: improved treatment and diagnostic options for patients; lower healthcare costs; the development of new industries that will lead to United States-based jobs; and manufacturing advances that are more reliable, lower cost and high quality,” said Gottlieb in the statement.

Should the proposed budget be implemented, the FDA has a ready list of initiatives it would pursue, including creating a new medical data enterprise by using real-world evidence, building a knowledge management system and portal for industry use, stimulating investment in drugs to treat rare diseases, and encouraging the approval and use of generics.