‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

After 10 years of biosimilars being on the market in the US, and more than 15 years after the Biologics Price Competition and Innovation Act framework was signed into law, Julie Reed – executive director of industry association the Biosimilars Forum – is clear that the time has come for change.

In an exclusive interview with Generics Bulletin covering the latest developments from the new Trump administration – as well as some of the more longstanding regulatory obstacles that are preventing biosimilars from reaching their full potential in the US – Reed outlined the changes that she would like to see at the US Food and Drug Administration in particular, while also pointing to the potential opportunities that accompany the recent political sea-change in the US.

“It’s the 15th year of the BPCIA and the 10th year since the first biosimilar,” Reed acknowledged, “and having been doing this for 15-plus years, this anniversary is very, very significant because of what needs to change.”

The Biosimilars Forum’s members “are very concerned about the long-term sustainability of the US biosimilar industry,” she said. “And I think people need to understand how serious that is.” Because while “we’ve had some successes, it’s absolutely been crazy how many barriers have been put in place.”

Some of these obstacles were “the market access barriers that we’ve been talking about for eons,” she suggested. For example, “we still need pharmacy benefit manager reform.” The Forum recently applauded the House of Representatives Committee on Energy and Commerce for including PBM reform in a first draft of Congress’s reconciliation package, with Reed insisting that “reforming the PBM monopoly” and creating a “competitive free market dynamic” was critical to lowering prescription drug prices for Americans and providing more lower-cost drug options such as biosimilars,” given the “waste and bureaucracy” created by “PBM middlemen” in the US health care system.

“But the other piece of it, which is really critical this year, is the FDA needs to change,” she told Generics Bulletin. And acknowledging that she was calling for some major changes, she said this was because the Biosimilars Forum and industry were now “in a position where I’d say our motto is ‘go big or go home’.”

Changes Needed To ‘Inefficient’ FDA Review Of Biosimilars

“There’s a need to evolve the way biosimilars are reviewed in the agency,” she urged. Praising Sarah Yim – director of the FDA’s Office of Therapeutic Biologics and Biosimilars – and her team, “who had basically built the biosimilar industry in the US from the ground up, with very few resources,” Reed nevertheless outlined obstacles that she saw in terms of how the FDA handled biosimilar applications.

“The agency continues to use the process of using the medical reviewers in each therapeutic division that are actually medical reviewers of innovative new products,” she pointed out. “Those reviewers are not the right people to review a biosimilar application any longer.”

“It was appropriate in the beginning, 15 years ago, because they were comparing the innovator product to the biosimilar,” she acknowledged. “But the science has evolved and the OTBB has evolved.”

“Biosimilar science is based on analytics, not clinical efficacy and safety testing, not clinical data,” Reed underlined. But the OTBB still “does not have signatory approval of a biosimilar application. That’s archaic. We can’t keep going on like this. We really, really can’t.”

“So FDA needs to, especially – and we’re hopeful that commissioner Makary will look at this – give the biosimilar scientists and FDA experts the ability to approve, to be on what’s called a BMER [Biosimilar Multidisciplinary Evaluation and Review], the form that everyone signs to approve a biosimilar.”

“They’re in charge of biosimilars, but they are not elevated to the level of ownership,” Reed complained, “and with the changes and resources at the agency, innovator products should be the focus of the innovator clinical reviewer.”

Ultimately, she said, “this is an internal FDA bureaucracy issue that needs to be taken down and changed. They’re not using the right reviewers to review a biosimilar application, and they’re internally interpreting that the BPCIA [says] only the innovator clinical reviewer can review. That’s not a good use of the FDA’s resources. It’s not efficient. We’ve had 15 years, let’s make a change. And that is the first thing that needs to happen.”

Three-Way PK Studies ‘Make No Sense’

Another proffered example of a regulatory obstacle – on which the Biosimilars Forum had submitted a citizen petition calling for change – was the FDA’s standard request for three-way pharmacokinetic bridging studies that compare US and non-US versions of originator drugs in biosimilar trials.

This was due to developers for the US market typically purchasing brand product for testing in Europe, where it is typically cheaper and more accessible than in the US.

“This routine requirement of these three-way PKs has been requiring us to test to prove the European product is the same as the US product,” Reed pointed out, “when there’s public data available that says it is. It’s just nonsensical at this time by now, and it needs to change.”

“Our citizen petition says, stop doing this. It’s inefficient, it’s costly, it’s slowing down development of a biosimilar and it makes no sense.” And if the FDA wanted to continue to routinely require such tests, she said, the agency should “tell us why – give us a reason.”

“It’s amazing that people think our companies are not scientific experts in biosimilar development,” she reflected. “The bias inside the agency continues to undermine biosimilar developers.”

“Again,” she said, this was an example of “internal bureaucracy, inefficient processes where the agency needs to change the way it does things. And it needs to evolve and move into the 15-year experience.”

Suffixes ‘Have No Value’

The four-letter suffixes added to the end of molecule names – introduced by the FDA years ago despite industry and regulatory opposition – were another example of an outdated element that needed to change, Reed said.

“No one uses the suffix,” she observed. “Across the board. There’s no value to it. And it’s one of those things that again, was put in place years ago by an agency that at that time didn’t know biosimilars, didn’t know… they were afraid they wouldn’t be safe, and they thought, we need to do this.”

“Well guess what? There’s not been a safety signal from a biosimilar in this country for the past 10 years. None of them. And the FDA wrote the paper on that.”

Asked whether the suffix issue was seen as ripe for revisiting, Reed suggested that a fresh approach could still be taken. “It’s FDA guidance. It’s not in statute,” she noted. “It was an FDA idea that is no longer necessary. It wasn’t necessary in the first place. And again, no one’s using it. So it has no value and it’s inefficient. That regulation needs to just be stopped and resources refocused internally to the right place.”

New Trump Administration Offers Opportunity For Change

Turning to recent political developments in the US, Reed acknowledged that there were some concerns over potential delays to the renewal of the biosimilar user fee program, BsUFA IV, amid turmoil and staff cuts at the FDA. To ensure timely review, “it’s critical that the FDA has its resources,” she said. “We are carefully watching this and are very concerned.”

But at the same time, Reed suggested, the recent change in administration offered “an opportunity to raise awareness” of the Forum’s priorities and how they aligned with those of the government.

“What they want to do is to change things, make things more efficient, take away burdensome regulations that make no sense, to put the resources in the right place and use the right resources,” Reed said. “So we really appreciate the viewpoint of this administration.”

“Like any trade association, we are non-political, we’re bipartisan,” she underlined. “And if there’s any program that needs more efficiencies, and to evolve to reflect the science and how biosimilars come to market, and everything else, it’s the FDA and the OTBB and the bureaucracy inside the agency.”

What the Forum wanted to avoid, she said, was any kind of de-prioritization of biosimilars as the FDA deals with staff cuts and new management. “We are definitely concerned,” she said. “And some of the cuts that we are hearing about are folks who support everything, all the processes. And if you don’t have the support people behind the reviews and things like that, the processes will slow down.”

Nevertheless, she suggested that the OTBB was “the most efficient group – and if we could just empower them with signatory approval and changes, they could do much more with a small amount of resources.”

“They know what to do, they just need to be able to do it.”

Biosimilars Must Remain Free From Tariffs

Reed said that the Biosimilars Forum was also engaging with the Trump administration on the subject of trade tariffs.

“We appreciate the president’s perspective on tariffs,” she stated. “We don’t have tariffs on biosimilars at present. We are reaching out and explaining what will happen if a tariff is added to a biosimilar product. We’re concerned at what that will do to our cost. And our goal with biosimilars is low-cost products.”

In the wake of the Trump administration’s recent announcement of a Section 232 investigation into the pharma sector, Reed said biosimilars were “integral to the overall integrity of the American pharmaceutical supply chain and should be free from any tariffs so these medicines can continue to provide significant cost-savings.”

“Biosimilars are a commonsense solution to skyrocketing drug costs for Americans,” she underlined “but tariffs on the biosimilar industry could end the promise of lower-cost prescription drugs forever.”

Moreover, “import restrictions on biosimilars would undermine key administration objectives” on lowering drug prices,” Reed suggested. And for all stakeholders, she said, “whatever we can do to maintain our competitiveness and keep our costs low is really important.”

Outside of tariffs, she volunteered, “we are encouraged that president Trump, in his executive orders, has said we need to do more for generics and for biosimilars, and that he believes in and supports them.” As such, she said, “we’re hopeful that he will consider our recommendations and our thoughts about the potential impact to the cost of biosimilars.”

Developers Are Reconsidering Investments

Asked whether 2025 represented a banner year for US biosimilars – along with launches of Stelara (ustekinumab) biosimilars and Soliris (eculizumab) rivals earlier this year, the market is expecting imminent launches of denosumab challengers to Prolia/Xgeva and also a Tysabri (nataliuzumab) biosimilar launch by the end of the year – Reed said “it is, but this is where again, we’re going to go with our theme of: we’re very concerned and things need to change.”

Referring to the recent IQVIA report on the “biosimilar void” – reflecting the lack of biosimilar competition for most of the biologics that are facing an upcoming loss of exclusivity over the next decade – she said this was “a clear sign of biosimilar companies reconsidering where they put their money and how many biosimilars are developed. And that’s where we are sounding the bell that things have to change.”

“We need these changes,” she emphasized. “They’re simple, they’re efficient, they reduce bureaucracy. It just needs to be done. We’ve been talking about all this stuff for how many years? It needs to happen. There are no longer any excuses that work any more.”

“We have proved every piece of misinformation wrong,” Reed indicated. “We’ve proved every process that has been put in place as a barrier because of bias that biosimilars could be unsafe. They’re not unsafe. They’re wonderfully safe. Incredibly safe.”

“They don’t need suffixes. We don’t need three-way PK studies,” she reiterated. “People biased against biosimilars need to sit down and stop and get out of the way and let the industry flourish. Everybody, the whole ecosystem will be better off.”

And “if you look at the Inflation Reduction Act,” she said, biosimilar competition to brands could actually help them avoid the damaging effects of price negotiation. “If the innovators would help support biosimilars, we could bring more biosimilars to the marketplace and they can get exempt from negotiation,” she suggested. “I mean, that’s a win for the innovator as well.”