Biosimilars Month in Review: May 2024

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The biosimilars month in review highlights recent FDA approvals and successful comparison trials.

Biosimilars Month in Review: May 2024

The biosimilars month in review highlights the expansion of treatment options for patients with chronic inflammatory diseases. Recent US Food and Drug Administration (FDA) approvals signify significant progress in biologic therapies, potentially enhancing outcomes and improving access to treatment. Additionally, studies on biosimilars such as CT-P13 demonstrated comparable efficacy and safety to reference biologics, underscoring the importance of biosimilar adoption in maintaining positive treatment outcomes and patient satisfaction in chronic conditions like Crohn's disease.

Recent FDA Approvals

This month, FDA endorsements underscored progress in treatment options and accessibility for chronic inflammatory diseases and rare conditions, marking significant leaps forward in biologic therapies. These endorsements could potentially improve patient outcomes and access to critical treatments.

FDA Approves High-Concentrate, Citrate-Free Formulation of Biosimilar Adalimumab-adbm

The FDA has approved the high-concentrate, citrate-free formulation of subcutaneous adalimumab-adbm (Cyltezo), an interchangeable biosimilar to the reference product, adalimumab (Humira). The tumor necrosis factor (TNF) blocker has been approved to treat multiple chronic inflammatory diseases, including moderate to severe rheumatoid arthritispsoriatic arthritisplaque psoriasis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa.

“With this FDA approval, we are now able to offer both high- and low-concentration, citrate-free formulations of Cyltezo, further expanding treatment access for patients living with certain chronic inflammatory diseases,” Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim, stated.

FDA Approves First Interchangeable Biosimilars to Eylea

A pair of biosimilar products, aflibercept-jbvf and aflibercept-yszy, was approved by the FDA as interchangeable biosimilars to aflibercept (Eylea), making them the first interchangeable biosimilars to Eylea.

The approvals were based on a comprehensive review of scientific evidence demonstrating each product was highly similar to reference aflibercept, respectively, and there were no clinically meaningful differences from reference aflibercept. The FDA also pointed out multiple lots of Yesafili or Opuviz were compared to multiple lots of aflibercept across a range of different quality attributes, which confirmed similarity in structural and functional features.

FDA Approves First Interchangeable Biosimilar to Eculizumab for PNH and aHUS

The FDA announced the approval of eculizumab-aeeb (Bkemv) as an interchangeable biosimilar to eculizumab (Soliris) for the treatment of treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis as well as atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Announced on May 28, 2024, the decision marks the agency’s 53rd approval for a biosimilar in the US but the first interchangeable biosimilar approval to eculizumab in the treatment of PNH to reduce hemolysis and aHUS for inhibiting complement-mediated thrombotic microangiopathy.

CT-P13 Shows Promise in IBD Management

Since its launch, infliximab, the first biologic drug for approved inflammatory bowel disease (IBD), has been shown to significantly reduce the need for hospitalization and surgery, improve mucosal healing and fistula closure, and has led to sustained remission among these patients.

However, despite these advantages, biologics are generally less cost-effective compared with conventional treatments and can cause a significant financial burden on health systems. Therefore, after the patent expiration of the originator infliximab, biosimilar versions—such as CT-P13—were developed to combat this.

Remission Rates Comparable Between Biosimilar CT-P13, Originator in Bio-Naïve Crohn’s Disease

In the retrospective, multicenter study, investigators used patient data from 3 hospitals in Chiba-city, Japan to confirm the safety and efficacy of the TNF-α biosimilar among these patients. To do so, they compared the remission rate at week 54 in patients who were receiving either the reference product or CT-P13 using the medical records of patients diagnosed with Crohn’s disease between January 2004 and November 2019.

At week 54, the clinical remission rate among patients receiving the originator was 92.5% compared with 100% in the CT-P13 group. Additionally, endoscopic scores significantly decreased from baseline across treatment arms, with a mucosal healing rate of 53% in the infliximab group and 64% in the biosimilar group.

Infliximab Biosimilar CT-P13 Superior to Placebo for IBD Maintenance

According to results of 2 randomized, placebo-controlled, double-blind, multicenter, parallel-group phase 3 studies, a subcutaneous (SC) injection of infliximab biosimilar CT-P13 was proven to be a more effective maintenance therapy than placebo in patients with moderate to severe active Crohn’s disease or ulcerative colitis who initially responded to CT-P13 intravenous (IV) induction.

“These trials provide not only an assessment of the efficacy and safety of a novel exposure profile with infliximab in IBD but also benchmark the efficacy of CTP13 SC using endpoints incorporated into the pivotal program of IBD since the initial approvals of infliximab,” wrote a team of investigators led by Stephen B Hanauer, MD, professor in the Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University, Feinberg School of Medicine.

Comparative Analyses in Adalimumab Biosimilars

Studies involving adalimumab biosimilars demonstrated the importance of biosimilar adoption in maintaining patient satisfaction, adherence, and ultimately, positive treatment outcomes in chronic conditions.

Similar PK Observed Between High-Concentration, Reference Adalimumab-adbm

In the 14-week, double-blind, randomized, single-dose, parallel-arm phase 1 VOLTAIRE-HCLF trial, investigators enrolled a cohort of healthy, adult volunteers to compare the bioavailability of citrate-free, high-concentration and reference formulations of adalimumab-adbm. They also assessed the immunogenicity, tolerability, and safety of the formulations.

The citrate-free, high-concentration formulation and reference formulation of the biosimilar adalimumab-adbm showed comparable pharmacokinetic (PK) and immunogenicity profiles among a cohort of healthy participants, although both concentrations were shown to be safe and well-tolerated.

Patients with Crohn’s Disease Satisfied with Switch to Adalimumab Biosimilar SB5

A real-world mimicking study of patients with Crohn’s disease transitioning between adalimumab to the biosimilar SB5 revealed comparable sustained baseline clinical status across treatment groups. Patients reported both favorable disease control and treatment satisfaction.

“Treatment satisfaction has been positively associated with adherence, which is therefore expected to impact outcomes, as well as minimizing the nocebo effect,” wrote a team of investigators including Clare Harris, PhD, MSc, Faculty of Medicine at the University of Southampton, UK. “From the patient perspective, successful transition has more subtle and subjective feature and therefore is critical to the successful implementation of biosimilar medicines.”

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