Biosimilars Month in Review: February 2024

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This month’s biosimilars month in review underscores the evolving landscape of biosimilars, emphasizing their potential benefits in terms of safety, cost-effectiveness, and increased treatment options, while recognizing the importance of addressing challenges in adoption and perception.

FDA Approves Humira Biosimilar Adalimumab-ryvk

The US Food and Drug Administration (FDA) has approved adalimumab-ryvk (Simlandi), the first interchangeable, high-concentration, citrate-free biosimilar to adalimumab (Humira). The tumor necrosis factor (TNF) inhibitor is approved for the treatment of a variety of autoimmune conditions, including rheumatoid arthritis (RA), juvenile idiopathic arthritis, Crohn’s disease, ulcerative colitis, psoriatic arthritis (PsA), plaque psoriasis, ankylosing spondylitis, uveitis, and hidradenitis suppurativa.

The approval was based on analytical, non-clinical, and clinical data from 3 multicenter, randomized trials which demonstrated the safety, efficacy, and biosimilarity of adalimumab-ryvk compared with the reference product.

"Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients,” stated Eric Hughes, MD, PhD, the executive vice president global R&D and chief medical officer at Teva said in a statement. “This approval marks an important milestone for Teva and Alvotech’s partnership to collaborate on 7 biosimilars and expand the availability, access, and uptake of biosimilars in the US.”

Biosimilars for the Treatment of IBD

The use and impact of biosimilars for the treatment of inflammatory bowel disease (IBD) were highlighted in this month’s IBD news, underscoring the cost-effective use of biosimilars while also drawing attention to the importance of monitoring interchangeability and considering the risk of adverse events, particularly an increased frequency of severe adverse events when patients switch from the reference drug to a biosimilar.\

Interchangeability, Adverse Event Considerations for Adalimumab Biosimilars in IBD

A real-world study comparing adalimumab biosimilars to the reference drug in patients with IBD highlighted greater persistence among those taking a biosimilar but similar clinical response rates and biomarker reductions.

Findings support the cost-effective use of biosimilars but also emphasize the importance of monitoring interchangeability and adverse event risks, calling attention to an increased frequency of severe adverse events among patients who switched from the reference drug to a biosimilar.

“Our observations indicate that when transitioning from an original to a biosimilar or when using multiple biosimilars interchangeably, there may be an increased risk of adverse effects, ultimately impacting treatment outcomes,” investigators concluded.

Nonmedical Switch to Infliximab Biosimilar Safe, Linked to Cost Savings in Children with IBD

Despite the growing armamentarium of drugs to treat IBD in adults with Crohn disease or ulcerative colitis, children with IBD only have 2 FDA-approved treatment options: infliximab and adalimumab. Like most biologics, these treatments are often associated with high costs and limited patient access, both of which can be remedied with the use of biosimilar alternatives that have no clinically meaningful differences from the reference product but are often available at a fraction of the cost.

“Previous studies confirm the safety of a nonmedical switch in the adult population, but the clinical effectiveness and safety of switching in children and young adults is not as well established,” wrote Megan McNicol, PharmD, of the Inflammatory Bowel Disease Clinic Team at Nationwide Children's Hospital, and colleagues.

To address this gap in research, investigators evaluated clinical outcomes in children and young adults with IBD following a nonmedical switch from the infliximab originator to a biosimilar, further estimating the cost savings associated with this switch.

Results revealed a one-time, nonmedical switch to an infliximab biosimilar resulted in comparable clinical efficacy for the subsequent 12 months in children and young adults with sable infliximab trough levels and without antibody development. Investigators also noted significant cost savings associated with biosimilar usage.

Trends in Switching to Biosimilars

More and more biosimilars have been entering the market, opening the room for a less expensive treatment option for treating rheumatic diseases, cancer, and other conditions.

This month’s articles center around the adoption and perception of biosimilars in healthcare. While the first article emphasizes the successful transition to biosimilars, underscoring the safety and efficacy of biosimilar options compared to the reference drug, the second article delves into the hesitation among originator users in Finland to switch to biosimilars, primarily due to a lack of biosimilar knowledge.

Efforts to Increase Biosimilar Use Result in Successful Transition

In 2021, the University of North Carolina began an initiative to convert patients from the reference product to biosimilars based on market costs. This led to a retrospective analysis of the clinical outcomes of patients who were switched to a biosimilar, if clinically and financially appropriate, compared with those who were only treated with the originator or a biosimilar agent.

A total of 180 patients were included in the analysis, of which half (n = 90) were prescribed a biosimilar. During the observation period, 25 (13.9%) of patients were started and maintained on a biosimilar, 54 (30.0%) were switched from the originator to a biosimilar, and 11 (6.1%) were switched from a biosimilar to the reference drug.

Of those who received a biosimilar, most (87.8%) were maintained on a single biosimilar without the need to switch to an alternative infliximab product. These results underscored the safety and efficacy of these biosimilar options in comparison to the reference drug.

A total of 35 adverse effects were reported during the study period, of which approximately half (n = 18, 51.4%) were attributed to the infliximab originator. The 17 adverse events in the biosimilar cohort represented 9.4% of the total study population.

Originator Users in Finland Hesitant on Using Biosimilars

A recent survey in Finland found originator users are against switching to biosimilars—primarily due to their lack of biosimilar knowledge—but biosimilar users are not opposed to the interchange between biosimilar and originators.

Investigators collected anonymous data from 88 community pharmacies around Finland between May – October 2022. The survey took the form of an electronic semi-structured questionnaire with 25 questions.

Since drugs were interchanged in pharmacies, respondents did not know if they were taking an originator or biosimilar—and many couldn’t tell the difference after taking the medication, either. Patients were most likely to use a biosimilar if the biological medicine was more recent.

Additionally, results demonstrated the longer the biologic medicine had been in use, the more likely it was about an originator and not switched to a biosimilar.