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12 Articles in Volume 18, Issue #4
A New Frontier in Migraine Management: Inside CGRP Inhibitors & Migraine Prevention
Assessment of Patients with Rheumatoid Arthritis or Osteoarthritis
Biosimilars in Rheumatology: How Popular Will They Be?
Case Studies in Regenerative Cellular Therapy: Tendinopathy and Osteoarthritis
Commentary: Make the Easy Choice for Care
Editorial: The Emergence of Trackable Pill Technology: Hype or Hope?
Editorial: The Practicality of Pain Acceptance
How to Avert Government Scrutiny When Prescribing Opioids
Letters to the Editor: DEA and Prescribing, the War on Statistics, Failing Treatments, Patients' Options
Meet the Migraine Game-Changers
Platelet-Rich Plasma and Stem Cell-Rich Prolotherapy for Musculoskeletal Pain
With concerns over opioids, could novel receptors be useful?

Biosimilars in Rheumatology: How Popular Will They Be?

Is the rush on among rheumatologists and other healthcare providers to turn to biosimilars?

With Angus B. Worthing, MD, Don L. Goldenberg, MD, and Bharat Kumar, MD, FACP

The US Food and Drug Administration has approved nine biosimilar drugs to date—the result of the 2009 Biologics Price Competition and Innovation Act, which paved an abbreviated approval pathway for these molecules—and six of these new medications are tumor necrosis factor (TNF) inhibitors aimed at treating rheumatology and other inflammatory diseases. How soon these medications (see Table I) make their way into the hands of patients, however, remains to be seen.

Biologics are the fastest growing medication class by far, and the promise of costs savings with biosimilars is huge. Rand Corporation researchers estimated that biosimilar versions of the biologics used to treat rheumatoid arthritis (RA) and cancer could cut healthcare spending in the United States by $54 billion over the next decade.1

So is the rush on among rheumatologists and other healthcare providers to turn to biosimilars? Not exactly, according to a trio of experts interviewed by Practical Pain Management. At least not yet. All cited a common glitch—so far, the biosimilars are not that much less expensive than their pricey originals, and reduced cost is the whole point.

Science vs Finances

“The American College of Rheumatology [ACR] is strongly supportive of doctors who support biosimilar [use] for their rheumatology patients,” said Angus B. Worthing, MD, chair of the ACR’s Government Affairs Committee, and coauthor of a recent ACR whitepaper2 on the subject. Although these products do not add a “therapeutic benefit,” as they are equally as effective as biologics, the price reduction could be significant.

The whitepaper documents how Denmark and Norway, for example, have realized a 60% or higher savings with the use of biosimilars compared to biologics.2 In the US, a 30% savings is hoped for, said Dr. Worthing. Challenges at play have to do with rebate reforms, step therapy requirements from health insurance companies, and the impact of pharmacy benefit managers on price. ACR is working with the Alliance for Transparent and Affordable Prescriptions to tackle these and other issues impeding biosimilar prescribing.

While pricing is worked out, Dr. Worthing said he remains optimistic, especially as competition among biosimilars progresses. “It could be that it takes two or three biosimilars [for each biologic] to drive competition.” He noted that prices are already starting to budge with the two on-market TNF biosimilars: ifliximab-dyyb (Inflectra) and infliximab-abda (Renflexis).

If higher savings start to happen in the US, Bharat Kumar, MD, FACP, a rheumatologist and immunologist in Iowa City, said he would “use biosimilars over biologics.” Dr. Kumar also serves as an associate program director of the Rheumatology Fellowship at the University of Iowa Hospitals and Clinics in Iowa City. To date, he said he has not been using a lot of biosimilars with his patients.

“I think it’s a wait-and-see attitude,” added Don L. Goldenberg, MD, a rheumatologist and professor emeritus of medicine and nursing at Oregon Health & Science University in Portland.

In Practice

As more biosimilars enter the market, there are a few considerations to keep in mind when prescribing. Physicians may want to explain to patients that the biosimilar will in fact work in a similar way as the biologic, said Dr. Worthing. The pathway for FDA approval is more rigorous for biosimilars than it is for generic medications. Regulators review ample data and clinical research to ensure the newer products are therapeutically equivalent to their reference products. Interchangeability among biologics and biosimilars is also being pursued with more specific regulatory guidance pending.

When making treatment decisions, antidrug antibodies (ADA) must be considered and addressed as the ADAs to a reference product may cross-react with the biosimilar. As noted by the whitepaper authors, “An important implication of the comparative immunogenicity studies carried out to date is that a patient who develops antibodies to a reference drug with resultant loss of clinical response should not be switched to its biosimilar."2

Another pertinent topic to communicate to patients, Dr. Worthing advised, is that of extrapolation. When a biosimilar is approved for use in one indication by the FDA, it may also be approved at the same time for any or all of the indications for which the original biologic is approved. That decision is made based on “the totality of the evidence,” or the big picture, he explained.

This concept also applies to the pediatric population, added Dr. Worthing. None of the biosimilars approved to treat rheumatologic and other inflammatory conditions have been researched in children, although several have been FDA-approved for pediatric indications by way of extrapolation. (In the United States, for instance, all three Remicade biosimilars have been indicated for treating pediatric Crohn’s disease.)

When talking to patients, Dr. Worthing recommends providers “frame the move to a biosimilar in a positive light.” Remind patients that physicians expect the biosimilars to be therapeutically equivalent to the biologics, and that “we are all hoping for reduced costs.”

Conclusion

Despite progress with new biosimilars coming on the market, there remains a need for biosimilars that can help to manage other chronic pain and inflammatory conditions, such as fibromyalgia and osteoarthritis, said Dr. Goldenberg.

Overall, “rheumatologists should not fear biosimilar medications,” said Dr. Kumar. He points to the strong evidence and expert opinion finding them as effective as the originator drugs. “There are a lot of moving parts… but in the long run, biosimilars hold the promise of lower drug prices and greater affordability,’’ he said.

Last updated on: June 8, 2018
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