Biosimilars Month in Review: June 2024


The biosimilars month in review underscores the efficacy and safety of biosimilars in rheumatology, including recent studies supporting the growing confidence in these treatments across disease spaces.

Biosimilars Month in Review: June 2024

The biosimilars month in review underscores the efficacy and safety of biosimilars in rheumatology, including recent studies supporting the growing confidence in these treatments across disease spaces. Findings show biosimilars are viable options that maintain or improve patient outcomes while offering potential cost savings. Additionally, regulatory discussions focused on streamlining approval processes to enhance patient access and affordability further stressed the ongoing impact of biosimilars in rheumatological care.

Efficacy and Safety of Biosimilars in Rheumatology

Recent studies highlight the increasing viability and efficacy of biosimilars in the treatment of rheumatoid arthritis (RA). Both the adalimumab biosimilar MSB11022 and the tocilizumab biosimilar CT-P47 demonstrated comparable safety and efficacy to their reference biologics, suggesting that biosimilars can sustain or even enhance patient outcomes while maintaining a robust safety profile. Additionally, the safety data underscore the potential for biosimilars to provide cost-effective alternatives without compromising treatment quality, thus expanding therapeutic options for RA patients.

Adalimumab Biosimilar MSB11022 Demonstrates Comparable Safety, Efficacy in RA

Among patients with RA, treatment with the adalimumab biosimilar MSB11022 was shown to sustain the prior benefits reported in previous adalimumab treatment, according to data presented at the 2024 European Congress of Rheumatology (EULAR). In some cases, treatment with the biosimilar led to greater improvements while maintaining a safety profile in line with previously described biosimilars.

After a median of 8 months follow-up, the median Disease Activity Score 28 in Rheumatoid Arthritis with C-reactive protein (DAS28-CRP) increased to 1.87 (1.22;2.29), with 86.0% (n = 74) of patients in remission and 94.2% (n = 81) with low disease activity. In this cohort, the median CDAI remained 4.00 (1.00; 5.00), with 39.5% (n = 24) of patients in remission and 95.3% (n = 82) reporting low disease activity.

CT-P47 Is Promising Biosimilar Candidate for Tocilizumab in RA Treatment

Investigators sought to compare the effectiveness and safety of the biosimilar CT-P47, a recombinant humanized monoclonal antibody that acts as an interleukin 6 receptor antagonist, with tocilizumab.

The primary endpoint was an improvement in DAS28 using the erythrocyte segmentation rate at weeks 12 and 24. The estimated difference in DAS28 improvement between the 2 groups was -0.01 for week 12 and -0.1 for week 24. The confidence intervals fit within the margins of the estimated differences, suggesting the 2 treatments are equivalent in terms of their DAS28 score (week 12: 95% CI, - 0.26 to 0.24; week 24: 90% CI, - 0.30 to 0.10).

“The positive topline results from the Phase III study support the biosimilarity of CT-P47 to reference tocilizumab and also provide clinical evidence for the possibility of switching from reference tocilizumab to CT-P47,” said Josef S. Smolen, MD, emeritus professor of medicine at the Medical University of Vienna, Austria, in a press release.

Patient Tolerance and Switching Patterns with Biosimilars

This month’s biosimilars headlines showcase their usage in rheumatic diseases and include the safety and efficacy of switching from originator biologics to biosimilars, particularly for juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) and psoriasis (PsO). The research indicates that switching to biosimilars, such as anti-tumor necrosis factor (TNF) agents, does not adversely affect disease activity or increase treatment discontinuation rates, providing reassurance to patients, families, and healthcare professionals.

Switch to Anti-TNF Biosimilar Well-Tolerated in Juvenile Idiopathic Arthritis

A matched comparative effectiveness analysis found no evidence that switching from an anti-TNF originator to a biosimilar product stopped treatment, or worsened disease activity, in patients with JIA.

“The results of this study show that switching from an originator to a biosimilar in a non-medical switch does not result in a significant change in disease activity or alter whether patients subsequently stop treatment, compared with those who continue the originator therapy, providing reassurance to patients and their families, as well as healthcare professionals,” wrote the investigative team, led by Lianne Kearsley-Fleet, PhD, Center for Musculoskeletal Research, The University of Manchester.

1 out of 3 Patients with PsA/PsO Switch, Swap Biologics Within 3 Years

Results of a study analyzing switches and swaps between originators and biosimilars among patients with PsA and PsO showed more than a third of patients changed therapies within a 3-year follow-up period.

Compared with anti-interleukin (IL) agents, patients receiving tumor necrosis factor (TNF)-α inhibitors were more likely to switch or swap. Anti-IL therapy was also linked to a reduced risk of multiple switches during a follow-up period.

Switching between therapies is common among patients with PsA and PsO, with estimates ranging from 5% to 30% during the first year of treatment. Reasons for switching include adverse events, loss of efficacy, and switching from a reference product to a lower cost biosimilar.

Regulatory and Economic Impact of Biosimilars

Recent discussions about biosimilars include the need for regulatory improvements and the economic impact of biosimilars on biologic prices. The Biosimilars Council has emphasized the importance of streamlining regulatory requirements to expedite the development and market entry of biosimilars, which would enhance patient access to affordable and effective treatments. Additionally, research shows that the introduction of biosimilars significantly reduces the prices of biologics both in the US and globally, demonstrating the potential cost-saving benefits of these medications.

Biosimilars Council Encourages FDA to Streamline the Development of Biosimilars

The Biosimilars Council published a new position paper outlining their suggestions regarding streamlining regulatory requirements for biosimilar development. These changes aim to enhance access, affordability, and efficiency in bringing these critical treatments to market faster.

“The absence of regulatory clarity about what, if any, clinical efficacy studies will be required, combined with this previous experience, means that sponsors generally plan to conduct comparative clinical efficacy studies as part of their development programs regardless of their scientific utility,” the authors wrote. “Some companies may decide to forego biosimilar development programs because of the projected expense, reducing patient access to these important, safe and effective, more affordable medications.”

Biosimilar Introduction Reduces Biologic Prices in the US and Globally

Prior research showed biologics prices reduced after introducing biosimilars in the market.However, the studies analyzed this with insurance claims data, failing to show negotiations and discounts between healthcare providers and insurers. The new study, led by Hui-Han Chen, MHS, BS, from the UNC Eshelman School of Pharmacy at the University of North Carolina, used annual global sales in the IQVIA MIDAS® database to examine the price fluctuations after introducing biosimilars.

Results revealed the price of biologics both globally and in the US significantly reduced following the introduction of biosimilars.

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