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Expert Panel Discusses Systemic, Policy Barriers to US Biosimilar Uptake


“We're always under the tyranny of the 10-year budgetary window that the CBO [Congressional Budget Office] models under,” said Rep. Michael C. Burgess, MD, R-Texas, in a discussion of the limitations of the US system for bringing biosimilars to the market.

Many systemic and policy hurdles impede the uptake of biosimilars in the US market, according to a panel of experts who spoke at the Biosimilars: Breaking Through the Barriers symposium earlier this month in Washington, DC.

“Despite the fact that many of us feel sort of tired because we've been doing this for 10, 12 or 15 years, we are at the same time in the beginning of this marketplace,” said panelist, Alex Brill, a resident fellow at the American Enterprise Institute, a conservative think tank based in Washington, DC.

Besides Brill, the panel consisted of Brett Baker, senior health policy advisor on the US Senate Committee on Finance; Wayne Winegarden, director of the Center for Medical Economics and Innovation and a senior fellow at the Pacific Research Institute in San Francisco, California; and Rep Michael C. Burgess, MD, R-Texas.

The panel was co-moderated by Marc Siegel, MD, a Fox News contributor, and Juliana Reed, vice president and global corporate affairs lead for Inflammation and Immunology at Pfizer.

The panelists discussed their commitment to expand biosimilar use in the United States and how physicians and government officials are looking to help.

Getting Biosimilars Legislation Passed

Burgess highlighted his own attempts at passing legislation including formulating a bill to update the FDA’s Purple Book, which lists biological products and licensing information.

“The good news is the FDA is actually going ahead with many of the things that were written about in that bill and the digitization of the [Purple Book] list of biologics is something the FDA has already undertaken. So, I'm grateful for that.”

The panel also mentioned other congressional bills aimed at increasing US biosimilar access, including the Grassley-Wyden bill that is currently waiting to be voted on as well as House bill HR 6179 and Senate bill S 3466, which were introduced to Congress on March 10 and 12, respectively.

Brill brought up that most legislation for biosimilars includes policies that focus on Medicare plans rather than employers and individual patients because “of the way Washington works…to encourage policymakers to pursue the policies that will drive biosimilar utilization by those types of things that will save money for the federal government.”

Burgess touched on the struggles with attaining bipartisan agreement, saying that it can be hard to look past the immediate future. “We're always under the tyranny of the 10-year budgetary window that the CBO [Congressional Budget Office] models under,” and “if you're only looking at the first 10 years, then all you see is expense. If you widen that case out and look at the next 10 years, then you will begin to incorporate some of those savings.”

Winegarden said leaving drug pricing decisions up to institutions can cause problems because patient welfare may be underemphasized.

Brill stressed that caution should be taken when analyzing discounts and potential price decreases in the European biosimilar market because these measures can lead to unrealistic predictions of how the United States will fair and make it harder to achieve uptake.

“We should not expect to see the same number of competitors, and we should not expect to see the degree of price discounting.” If the US metrics don’t follow those of the European market, that is not a failure, he said. “That's just the reality of being in a different marketplace with different dynamics.”

Failed Bid To Get Prices Into Drug Ads

Burgess lamented the failure of a Trump administration rule to force drug companies to include their drug prices in television ads. The rule was quashed by a federal judge in July. Now, Burgess said, patients who view ads will only be able to judge a drug based on whatever “celebrity” is in the commercial and how much they like them, when in reality, price disclosure could help patients make a better judgement.

Winegarden touched on drug manufacturers’ ability to retain patents and avoid competition by changing formulations and discontinuing older ones, a practice called product hopping. “If there's an innovation [to a reference product], we should still be able to get the biosimilar on the old formulation.” He said it’s unfortunate that patients are caught in the middle of these competitive maneuvers by pharmaceutical companies.

Despite these issues, Burgess remains optimistic for eventual policy aid to US biosimilar uptake, saying that in the same way Pfizer was able to mass produce life-saving penicillin during and after World War II, “biosimilars hold the promise of doing that in the biologic world.”

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