The biosimilars month in review reflects ongoing efforts to address key challenges in rheumatic disease treatment, including the need for accessible therapies, cost-effective alternatives, and reliable clinical data to guide treatment decisions and optimize patient care.

Recent FDA approvals

Recent US Food and Drug Administration (FDA) approvals of biosimilar versions of well-established monoclonal antibodies used to treat chronic autoimmune conditions highlight advancements in providing more accessible and affordable treatment options for patients, with biosimilars offering comparable efficacy and safety profiles to their reference products.

FDA Approves Biosimilar Ustekinumab-aekn for PsO, PsA

Alvotech and Teva announced the FDA approval of its ustekinumab (Stelara) biosimilar, ustekinumab-aekn (Selardsi), for the treatment of moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in both adults and pediatric patients aged ≥ 6 years.

The biosimilar, a monoclonal antibody, binds to the cytokines interleukin (IL)-12 and IL-23, both of which are involved in treating immune-mediated diseases like PsO and PsA. It is expected to be marketed in the US on or after February 21, 2025.

Tocilizumab-aazg Officially Launches in the US for Chronic Autoimmune Diseases

The tocilizumab biosimilar, tocilizumab-aazg (Tyenne), became officially available in the US in April. The drug, which is Fresenius’ third FDA-approved biosimilar available in the US, is used for the treatment of chronic autoimmune diseases, including rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (JIA), polyarticular juvenile idiopathic arthritis (PJIA), and giant cell arteritis.

First achieving FDA approval on March 5, 2024, it is the first focilizumab biosimilar with both intravenous and subcutaneous approved formulations.

Legislation Increases Awareness, Optimism

Increasing Legislative Changes May Mark Turning Point in US Biosimilar Adoption

As biosimilars are a market-based solution to help with the affordability of specialty drugs in the US—in particular adalimumab in the rheumatic space—there is a real opportunity for patients to be part of the savings.

Despite the many challenges, there is hope surrounding the commitment of biosimilar developers to offer cost-effective options, with efforts underway to circumvent pharmacy benefit managers (PBMs) and increase patient access.

For example, in October 2023, the Department of Health and Human Services (HSS) Secretary Xavier Becerra released a statement regarding the approval of ustekinumab-auub, an interchangeable biosimilar, for the treatment of inflammatory diseases. Additionally, the introduction of the Inflation Reduction Act helped to encourage competition within the market by removing some of the barriers that were blocking biosimilars and generic drugs from entering the market.

Further, in 2021, US senators Michael Bennet and John Cornyn introduced the Increasing Access to Biosimilars Act, which aimed to increase the availability of biosimilar biological products under the Medicare program.

Efficacy of Biosimilars in Treating Rheumatic Disease

This month’s articles collectively showcase significant advancements in the field of rheumatology and autoimmune disease management through the development and evaluation of biosimilar medications and highlight their potential to enhance patient outcomes and treatment accessibility.

Proposed Golimumab Biosimilar AVT05 Meets Primary Endpoints in Moderate to Severe RA

Alvotech’s proposed golimumab biosimilar, AVT05, met its primary endpoints in a confirmatory clinical study evaluating the biosimilar for the treatment of moderate to severe RA.

Results were derived from a randomized, double-blind, 2-arm, multicenter confirmatory clinical study, AVT05-GL-C01, which evaluated the safety, efficacy, and immunogenicity between the proposed biosimilar and reference drug in patients with moderate to severe RA. The primary endpoint was the change from baseline to week 16 in Disease Activity Score-28 for Rheumatoid Arthritis with C-reactive protein (DAS28-CRP).

“We are delighted at passing yet another clinical milestone in our pipeline,” Robert Wessman, Chairman and CEO of Alvotech, said in a statement. “We intend to file marketing applications for AVT05 in major global markets this year, which adds to the continued diversification of our portfolio and further demonstrates the capabilities of our biosimilar-dedicated platform.”

Secukinumab and Sandoz Adalimumab Have Similar Outcomes When Treating r-axSpA

Separate trials for secukinumab and Sandoz adalimumab showed the treatments can improve symptoms of r-axSpA and both were linked to low rates of radiographic progression. Secukinumab and Sandoz adalimumab are both approved by the FDA to treat r-axSpA. However, the 2 treatments were never compared to see which one had a lower rate of radiographic progression.

The new SURPASS study found patients with radiographic axial spondyloarthritis (r-axSpA) treated with secukinumab (IL-17A inhibitor) and the biosimilar Sandoz adalimumab (SDZ-ADL; TNF inhibitor) had no significant differences in the effectiveness of the treatment.

IFX-dyyb Boosts Rheumatoid Arthritis Outcomes in 6 Months

A recent study evaluating IFX-dyyb, an infliximab biosimilar, in patients with RA revealed promising outcomes, with notable improvements in disease activity and patient-reported outcomes observed over 6 months, particularly among those switching from non-IFX biologic/ts disease-modifying antirheumatic drug (b/tsDMARD) or b/tsDMARD-naïve patients. These improvements stayed the same for patients switching from IFX-REF/IFX biosimilar.

“The present study provides data that are reflective of situations in clinical practice, where patients may switch to a biosimilar from the originator or from other biologic DMARDs or tsDMARDs,” wrote investigators, led by Joshua F. Baker, MD, MSCE, from the University of Pennsylvania. “Our findings suggest that outcomes at 6 months with IFX-dyyb treatment in the real-world setting are comparable with efficacy outcomes in clinical trials.”