Current Issue : July-September Volume : 2026 Issue Number : 3 Articles : 5 Articles
Objective: This study evaluated the efficacy and safety of the biosimilar Rimmyrah versus the reference ranibizumab in patients with diabetic macular edema (DME). Methods: This retrospective study included 70 patients with DME. They were divided into two groups: 35 patients (35 eyes) received the reference ranibizumab, and 35 patients (35 eyes) received the biosimilar ranibizumab. All patients were treated following a 3+ pro re nata (PRN) regimen. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were compared between the groups at 3, 6, and 12 months post-treatment. Additionally, the foveal avascular zone (FAZ) area and macular vessel density were compared at baseline and 12 months, along with the total number of intravitreal injections required. Results: There were no statistically significant differences between the two groups in BCVA or CRT at any time point (all P > 0.05). Consistent with the therapeutic effect of ranibizumab, both groups showed significant improvements from baseline in BCVA and CRT (all P < 0.05). Similarly, no intergroup differences were found in FAZ area, superficial vascular density (SVD), or deep vascular density (DVD) at baseline or 12 months (all P > 0.05), with both groups exhibiting significant within-group improvements post-treatment (reduced FAZ, increased SVD and DVD; all P < 0.05). No statistically significant difference was observed in the mean number of intravitreal injections between the reference ranibizumab group (3.43 ± 0.65) and its biosimilar group (3.69 ± 0.76) during the study period (P = 0.1530). No treatmentrelated serious ocular or systemic adverse events occurred in either group during the 12-month follow-up. Conclusion: The ranibizumab biosimilar (Rimmyrah) showed similar safety and efficacy profiles to its reference product in the treatment of diabetic macular edema....
EGFR signaling, which requires ligand shedding by ADAM proteases, drives the progression of a variety of cancers, including breast, ovarian and lung. We previously reported the generation and characterization of a fully human, affinity-matured anti-ADAM17 monoclonal antibody, D8P1C1, which inhibits both the proliferation of an array of cancer cell lines in vitro as well as breast cancer growth in a mouse xenograft model. Here, we show that the mAb inhibits the shedding of EGFR ligands and EGFR phosphorylation in cancer cell lines, thus explaining its anti-tumor effects. In a xenograft model with a high-grade serous ovarian cancer (HGSOC) cell line, D8P1C1 showed only modest therapeutic effect, without any discernible toxicity. These results suggest that ovarian cancers are less susceptible than breast cancers to therapeutic targeting of ADAM17- or EGFR-dependent signaling. Radioimmuno PET imaging with 89Zr-DFO-D8P1C1 confirmed tumoral accumulation of the mAb in high-grade and non-high-grade serous ovarian tumor xenografts. Furthermore, we report the generation and preliminary characterization of a bispecific T cell engager derivative of D8P1C1 with improved anti-tumor efficacy in vitro....
Background: Adalimumab is a mainstay treatment for hidradenitis suppurativa (HS); however, high-costs limit accessibility. While biosimilars offer an affordable alternative, concerns remain regarding clinical equivalence and the impact of switching. Objective: To evaluate the clinical response of originator versus biosimilar adalimumab in HS and assess outcomes following nonmedical switching. Methods: This multicenter, real-world study included treatment na€ıve HS patients initiated on originator or biosimilar adalimumab between April 2021 and December 2024. Outcomes were compared between patients remaining on originator and those switched to biosimilar after 16 weeks. Clinical responses were assessed using Hidradenitis Suppurativa Clinical Response 50, Hidradenitis Suppurativa Clinical Response 75, and International Hidradenitis Suppurativa Severity Scoring System 55, with time-to-event analyses evaluating loss of clinical response. Results: Patients on originator adalimumab (n = 186) demonstrated greater proportions of clinical response than biosimilars (n = 127), with time-to-event analysis showing a significant difference between curves (100 vs 52 weeks; hazard ratio = 2.73; P < .0001). Patients switched to biosimilars (n = 71) and experienced higher rates of loss of response than those maintained on originator (n = 71) (50 vs 87 weeks; hazard ratio = 2.42; P = .0003). Limitations: Limitations include its retrospective design and variable biosimilar formulations. Conclusion: Significant differences in clinical response, loss of response, and time-to-event analysis between originator and biosimilar adalimumab in HS underscore the need for consistent treatment and robust monitoring to optimize management. ( JAAD Int 2026;24:9-15.)....
Background/Objectives: To assess the clinical similarity in terms of efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety, and immunogenicity between MB09 (denosumab biosimilar) and the reference product [RP, (Prolia®)] up to 18 months in women with postmenopausal osteoporosis (PMO). Methods: Women with PMO received three doses of 60 mg of MB09 or RP subcutaneously, every 6 months [two doses in the main treatment period and one dose in the transition period (TP)]. The primary efficacy endpoint was the percent change from baseline (%CfB) in lumbar spine bone mineral density (BMD). Secondary endpoints included other efficacy parameters and PD, PK, safety, and immunogenicity assessments. Results: A total of 555 subjects received MB09 (N = 278) or RP (N = 277). At month 12, %CfB in lumbar spine BMD was comparable between groups (MB09 versus Prolia) and met the predefined equivalence margins. Secondary efficacy endpoints—%CfB in lumbar spine BMD at 6 months and %CfB in hip and femoral neck BMD at 6 and 12 months—were similar between groups. PD marker (serum carboxy terminal cross linking telopeptide of type I collagen) was similarly suppressed in both groups, and the inhibition was maintained in the TP. PK results showed similar denosumab systemic exposure for MB09 and the RP. Both study treatments were well tolerated with similar safety profiles throughout the study period. The incidence of anti-denosumab antibodies was very low. Conclusions: MB09 demonstrated equivalent efficacy to the reference denosumab in women with PMO. All secondary efficacy endpoints, together with PD, PK, safety, and immunogenicity assessments, supported MB09 as a denosumab biosimilar (NCT05338086, EudraCT No. 2021-003609-24)....
Background: In biosimilar studies, assessing the switchability and interchangeability of biosimilars with their reference products is essential for ensuring reliable clinical evaluation. This study explores optimal trial design strategies incorporating balanced and uniform structures to enhance statistical efficiency in treatment effect under a carryover setting. Methods: Using a linear mixed-effect model for log-transformed responses, we conducted a theoretical variance-based evaluation of all possible two-treatment switching designs in three-period and four-period crossover trials, considering settings with and without carryover effects. A total of 247 distinct three-period designs and 65,519 distinct four-period designs were enumerated and classified according to structural properties, with particular attention to those incorporating a non-switching arm (NSA). Results: SBUwP-NSA (Strongly Balanced Uniform-within-Period designs with a Non-Switching Arm) consistently achieved the minimum variance for treatment effect estimation in both carryover and no-carryover settings. In the absence of carryover effects, UwP-NSA (Uniform-within-Period designs with a Non-Switching Arm) attained equivalent efficiency. In contrast, commonly used dedicated switching designs exhibited substantially lower relative efficiency, achieving as little as 50–55% of the efficiency of the optimal designs, depending on carryover assumptions. Conclusions: This comprehensive theoretical evaluation demonstrates that incorporating strong balance and uniformity properties can yield substantial efficiency gains in switching studies. The results provide quantitative guidance for selecting efficient crossover designs, enabling improved estimation precision while maintaining practical relevance for interchangeability and switching assessments in biosimilar research....
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