- The Food and Drug Administration said Thursday it is pulling back a biosimilar draft guidance that aimed to assist drugmakers comparing the analytical similarity between a reference product and a biosimilar in development.
- The agency says the draft guide, issued in September 2017, raised concerns among industry, which said it would cause a range of issues that would adversely impact the cost and efficiency of biosimilar development if finalized as written.
- A new draft guidance to be promulgated in the future by FDA will address some of the issues raised in comments. The new guidance “will focus on providing appropriate flexibility for sponsors in order to help spur the efficient development of biosimilars without compromising the agency’s rigorous scientific standards for evaluating marketing applications for biosimilars.”
The biosimilar market in the United States has been slow to develop; to date, only 11 biosimilars have been approved by FDA, and many are not yet marketed due to litigation. FDA Commissioner Scott Gottlieb has been vocal criticizing healthcare players including pharmacy benefit managers, insurers and branded drug makers for improperly impeding biosimilars’ ability to enter the market.
Gottlieb said the pullback of the draft guidance is evidence FDA is committed to promoting market acceptance of biosimilars, which he says will lead to more affordable treatment options for patients.
"As the cost to develop a single biosimilar product can reach hundreds of millions of dollars, it’s important that we advance policies that help make the development of biosimilar products more efficient, and patient and provider acceptance more certain,” Gottlieb said.
The Association for Accessible Medicines said on Twitter it appreciates the move by FDA, which will “focus on making biosimilar development as efficient as possible to enhance competition that works for patients seeking relief from high specialty drug prices.”
In comments on the original draft guide, AAM raised concern that the number of reference lots the draft guidance recommended may be over encompassing.
"It would be more appropriate to restrict the accounting of all reference product and biosimilar lot analyses to those which are used after the processes and methods are settled,” the group wrote, adding that FDA should allow reference product material purchased outside the U.S. to be used in analytical comparisons as long as bridging data is provided.
“The draft guidance specifies that all lots of reference product used in analytical comparisons be obtained in the U.S. This recommendation can be viewed as an unnecessarily resource burden both from a financial and timely access standpoint in biosimilar development,” AAM wrote.
FDA appears to be sympathetic to the cost concerns raised by AAM and other groups, saying it will address them in the future guidance.
“The goal is for future draft guidance to address potential challenges faced by biosimilar sponsors in designing studies that are intended to demonstrate that a proposed biosimilar product is highly similar to a reference product, including consideration of appropriate methods to analyze analytical data to account for potential lot-to-lot variability of the reference product,” FDA said.
The agency said it will continue to provide development-stage advice to biosimilar sponsors both through formal meetings as well as “other interactions with sponsors.”