Biocon Biologics, a subsidiary of Biocon announced new dermatology data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam. The results from two separate pivotal Phase 3 clinical studies supported interchangeability between adalimumab and adalimumab-fkjp as well as underscoring biosimilarity of bUstekinumab.
Uwe Gudat, MD, Chief Medical Officer, Biocon Biologics said, “The extensive range of new data being presented at EADV this year underscores Biocon Biologics’ commitment to a high-science portfolio of biosimilar medicines that meet the clinical needs of physicians and patients while providing important sustainability benefits to health systems. These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity without variation of clinical outputs in patients with chronic plaque psoriasis.”
Poster Title: Multiple switching between the biosimilar adalimumab-fkjp low concentration and reference adalimumab high concentration in patients with chronic plaque psoriasis: a phase 3, double-blind, randomised, parallel-group study
Authors: Sarika Deodhar, Subramanian Loganathan, Ramesh Ks, Gopi Ranganna, Shiyao Liu, Matthew A. Hummel Hummel, Stefan Daniluk, Anna Hanczewska, Kamelia Vekovska, Maria Zegadlo-Mylik, Grazyna Pulka, Elena Wolff-Holz
Abstract ID: 3809
Poster ID: P3241
Date/Time: 9:00am EDT, September 25, 2024
This study evaluated the pharmacokinetics (PK), efficacy, safety, and immunogenicity in patients with moderate to severe chronic Plaque Psoriasis (PPs) receiving adalimumab continuously and those undergoing repeated switches between reference adalimumab and adalimumab-fkjp. The primary objective was to evaluate interchangeability of low-concentration adalimumab-fkjp (40 mg/0.8ml) and high-concentration adalimumab (40 mg/0.4ml) by comparing adalimumab steady-state PK between switching and non-switching arms.
The overall number and proportion of patients with Psoriasis Area and Severity Index (PASI) responses and static Physicians Global Assessment (sPGA) success were highly similar between the two arms at week 28. Treatment-emergent Adverse Events were comparable between switching [54 subjects (29.8 per cent)] and non-switching arms [66 subjects (34.2 per cent)]. The overall number and proportion of patients with PASI responses and sPGA success were highly similar between the two arms at week 28.
This study confirmed that the subjects receiving adalimumab-fkjp low concentration and adalimumab high concentration in alternate fashion had highly similar time concentration curves compared to continuous administration of high-concentration reference adalimumab, and demonstrated PK equivalence between switching and non-switching arms. The overall data supports interchangeability between high-concentration adalimumab and low-concentration adalimumab-fkjp.
This study was conducted to fulfil the US Food and Drug Administration (FDA) requirement for designation as an “interchangeable” and has been submitted to the FDA.
Gudat, said, “For physicians, an important unmet need is understanding the comparative safety, efficacy and exposure of an adalimumab biosimilar formulated at a low concentration and high-concentration adalimumab at dose parity. The data from the study shows clearly that in patients the same safety, efficacy and exposure when used at dose parity can be expected for both products. This in the context of multiple switches between the reference product and the biosimilar as required of an interchangeability study.”
Poster Title: A Randomised, Double-blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Reference Biologic-Ustekinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis 28-week Results
Authors: Jacek Szepietowski, Adam Reich, Steven Feldman, Grazyna Pulka, Lally Mekokishvili, Nino Junior Tsiskarishvili, Inese Kolontaja-Zaube, Airi Poder, Gursharan Singh, Subramanian Loganathan, Elena Wolff-Holz, Sarika Deodhar, Ashwani Marwah, Sandeep Athalye
Abstract ID: 4382
Poster ID: P3266
Date/Time: 9:00am EDT, September 25, 2024
This Phase 3, randomised, double-blind, active controlled, parallel-group, multicenter study compared the efficacy, safety, immunogenicity, and pharmacokinetics (PK) of Bmab 1200 with the reference product ustekinumab in adult patients with moderate to severe chronic plaque psoriasis (Pso).
A total of 384 patients were evaluated for 52 weeks and the primary efficacy endpoint was percentage change from baseline ( per cent CFB) in PASI at Week 12. In the primary efficacy analysis at 28 weeks, Bmab 1200 and ustekinumab were equivalent and the data support biosimilarity. The study established equivalent efficacy and comparable safety of Bmab 1200 with ustekinumab in patients with moderate to severe chronic plaque Pso.
Gudat, said, “This pivotal trial of bUstekinumab clearly met the safety and efficacy endpoints, thereby fulfilling the expectations set for a biosimilar. bUstekinumab offers tangible promise for all patients qualifying for treatment with Ustekinumab.”