Phase 3b trial results presented at American Academy of Dermatology Virtual Meeting Experience 2020 confirmed that Boehringer Ingelheim (BI)’s adalimumab biosimilar candidate is comparable to that of the reference product.
A phase 3b clinical trial assessing Boehringer Ingelheim’s (BI) adalimumab biosimilar (Cyltezo) demonstrated that the safety, efficacy, and immunogenicity of the drug were comparable to that of the reference product (Humira, AbbVie).
The results of the study were published as part of the American Academy of Dermatology Virtual Meeting Experience 2020 that was held from June 12-14.
The study included 318 adult patients with moderate-to-severe chronic plaque psoriasis for 6 months or more and had received no more than 1 previous biologic agent and were treatment-naïve to adalimumab.
Findings from Study
Patients were randomized 1:1 to receive 40 mg subcutaneously every other week of either Cyltezo or reference adalimumab over a 24-week treatment period. A total of 286 patients with a 50% reduction in Psoriasis Area and Severity Index (PASI) at week 16 continued on the trial.
Investigators said 141 patients in the biosimilar cohort and 134 from the reference adalimumab cohort completed the entire 24-week treatment period.
PASI 75% response rates at week 24 showed a significant similarity between the 2 treatment groups, demonstrating a difference of 2.9% between the groups, which investigators said was “well within the predefined equivalence margins.” PASI 50%, 90% and 100% response rates between the groups were also similar.
The mean improvement in PASI at week 24 was 84.6% (95% CI, 80.7-88.6) for Cyltezo and 85.4% (95% CI, 81.5-89.4) for reference adalimumab.
The incidence for adverse events (AEs) was similar between both groups, with 66 patients (41.5%) in the biosimilar group and 71 (44.9%) in the reference product group experiencing 1 or more AEs.
Serious AEs reported in the Cyltezo group consisted of abdominal abscess, oral herpes, upper respiratory tract infection, congestive cardiomyopathy, and psoriasis. Those reported for the reference adalimumab group included furuncle, kidney infection, orchitis, transient ischemic attack, pericarditis, chronic pancreatitis, toxic hepatitis, exostosis, foot deformity, and renal colic.
A similar proportion of patients in each group developed anti-drug antibodies and neutralizing antibodies by week 24, suggesting a comparable immunogenicity profile between the biosimilar and reference product. The PASI 75% response rate was lower among patients who were positive for drug antibodies than those who were not.
In 2018, researchers shared the results from another phase 3b study (VOLTAIRE-RAext) that demonstrated similar immunogenicity profiles of 2 adalimumab products.
More on Cyltezo
Cyltezo was approved for marketing in the United States in 2017 but is unable to come to market until at least 2023 due to Humira’s patent protections. It is 1 of 6 approved adalimumab biosimilars in the United States.
In 2017, BI initiated the VOLTAIRE-X trial to evaluate interchangeability of Cyltezo with reference adalimumab. In the United States, interchangeability at the pharmacy level is considered a separate designation from FDA marketing approval that requires additional clinical trials to obtain.
The drug was approved by the European Medicines Agency in 2017 but was withdrawn in 2019 when BI decided to focus solely on launching its biosimilar product in the United States and forgo European launches.
Top 5 Most-Read Rheumatology Articles of 2024
December 30th 2024The top 5 rheumatology biosimilar articles of 2024 highlight significant FDA approvals, including high-concentration adalimumab and tocilizumab biosimilars, along with evidence supporting the safety and efficacy of biosimilar-to-biosimilar switching.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Stable Patient Satisfaction Found After Switching From the Humira or Biosimilar CT-P17
December 14th 2024A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.