Biologic Therapies Summit

Biologic Therapies Summit

May 16, 2019
3 min read

US should ‘learn from Europe’ regarding biosimilar policy, adoption

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John J. Cush

CLEVELAND — The United States continues to lag far behind Europe in terms of biosimilar availability, and officials here should take a lesson from their peers across the Atlantic in adopting this class of medication, according to a pair of presenters at the Biologic Therapies Summit.

“Right now, there are 16 biosimilars available in the United States, of which eight are in rheumatology and they all happen to be TNF inhibitors,” John J. Cush, MD, of the Baylor Research Institute, told attendees. “Of the 16 that are out there, less than half of them, I think, are currently in use.”

“The promise of biosimilars — of cheaper, more available therapies — has not yet been achieved,” he noted. “In contrast, the biologic market worldwide, or even in the United States, is many, many billions of dollars. Worldwide, the market for biologics is about $100 billion, whereas the market for biosimilars worldwide is only $4 billion, and almost all of that is going on in Europe, and especially in western Europe. Very little of it is happening in the United States.”

Arthur Kavanaugh

Cush, joined on stage by Arthur Kavanaugh, MD, of the University of California, San Diego, noted that the FDA has recently issued its final guidance on the approval pathway for biosimilars, which clarified for developers what constitutes interchangeability with a reference product.

However, according to Cush and Kavanaugh, once a biosimilar’s interchangeability is demonstrated – as well as its safety, efficacy and lack of immunogenicity – a patient’s medication could then be switched from a reference product to that biosimilar, possibly without the knowledge or consent of the physician.

“I think that many of us are seeing some of the infliximab biosimilars streaming into our clinic without our knowledge or consent, but that is what is happening,” Cush said. “As biosimilars become more available, you are going to have the issue that is happening now, in which a patient that I have was on Remicade [infliximab, Janssen], but is now receiving Inflectra [infliximab-dyyb, Celltrion/Pfizer], and I didn’t know anything about it. There was a switch, and I didn’t know anything about it.”

However, both presenters pointed out that studies in Europe have demonstrated that multiple switches between a biosimilar and its reference product may be tolerated without significantly impacting clinical efficacy.

According to Kavanaugh, this was demonstrated after the 2016 introduction of SB4 — now the FDA-approved Eticovo (etanercept-ykro, Samsung Bioepis) — a biosimilar of etanercept (Enbrel, Amgen), in Sweden. Initially, patients were switched from etanercept to the less expensive SB4. However, this drove down prices for the originator, which led to all of those patients switching back.


“If you look at our colleagues in the United Kingdom and Europe, they are switching all the time,” Kavanaugh said. “If you go to a restricted system like the VA, you might as well not write which ACE inhibitor you want — you might as well write ‘blank-opril’ — because they are going to give you whatever they bought that week that was cheapest. That is what is going on in the United Kingdom with the biosimilars, because every time they have a new one, they switch.”

Despite the potential loss of autonomy, Cush urged rheumatologists to counsel their patients on biosimilars in order to ease any fears they may have regarding a different class of medication.

“Most of us are thinking biosimilars are out there, they are cheaper, and they work,” he said. “However, we don’t like the autonomy regarding what is best for your patient being taken away, and that is a little upsetting. In turn, the patient gets worried when they hear about that, so they need the guidance from you about what is going on and what biosimilars are.”

Cush added that the European studies demonstrating the tolerability of multiple switching would not count toward meeting the criteria for interchangeability and allow those drugs to gain that label in the United States. To achieve that would require working with the FDA, and a prospective trial in which patients switch from the reference product to the biosimilar, and then either back to the original or to a third product, he said.

According to Cush, the United States is “years away” completing this process for any upcoming biosimilars.

“I think we are years from seeing something like that, because we are going to take a year or more to get these trials done,” he said. “However, these are important, and, what is important to us is that we need to learn from Europe about biosimilars and how you are going to adopt them.” – by Jason Laday

Cush JJ and Kavanaugh A. Immune-mediated inflammatory diseases roundup 2019. Presented at: Biologic Therapies Summit VIII; May 16-17, 2019; Cleveland, Ohio.

Disclosure: Cush reports consulting fees from AbbVie, Amgen, Aurinia, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Genentech, Horizon Pharma, Novartis, Pfizer and UCB, as well as contracted research for AbbVie and AstraZeneca. Kavanaugh reports contracted research from Abbott Laboratories, Amgen, Celgene, Eli Lilly, Novartis, Pfizer and UCB.