Biosimilars Action Plan to be Unveiled by FDA’s Gottlieb

Next Wednesday, July 18, has been set as the rollout date for Food and Drug Administration Commissioner Scott Gottlieb’s new plan to help bring biosimilar drugs to the market sooner. So far, Commissioner Gottlieb has revealed some broad strokes regarding the content of the Biosimilars Action Plan, but the exact measures it contains remain a mystery.

In a series of tweets on Sunday, he stated, “We will soon unveil a comprehensive Biosimilars Action Plan that will include policies and actions to improve the efficiency of FDA’s review of biosimilar marketing applications and increase regulatory certainty for biosimilar manufacturers and other stakeholders.”

Gottlieb announces Biosimilars Action PlanHe indicated that it will consist of education on biosimilars as well as “reducing gaming that may delay market competition.” Outside of taking action to prohibit “authorized generic” agreements, tools that he can use may be somewhat limited, without legislative action.

Dr. Gottlieb also pointed to “providing clarity for product developers via guidance and meetings.” This may have been prompted by the recent withdrawal of a guidance on statistical analysis. The guidance had drawn the ire of biosimilar advocates. Questions still loom over the question of interchangeability and the requirements for approval. This still clouds one of the most promising pathways for biosimilar adoption.

Much has been written about harmonizing international biosimilar regulatory policies, and one wonders whether Commissioner Gottlieb’s call on this will put enough wind in its sails to get underway.

“Although there are barriers to marketing biosimilars outside FDA’s purview,” Dr. Gottlieb tweeted, “we’re committed to advancing policies to facilitate efficient development, approval of biosimilars to reduce costs, enhance access, without reducing incentives to innovate. #BAP will advance these goals.”

For those interested in hearing Dr. Gottlieb introduce his Biosimilars Action Plan first hand, please visit https://www.brookings.edu/events/u-s-market-for-biosimilars-fda-scott-gottlieb/.

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