Current Issue : April-June Volume : 2026 Issue Number : 2 Articles : 5 Articles
Biopharmaceuticals are medical drugs produced by means of biotechnology. In contrast with small-molecule (traditional) drugs, which are usually synthesized chemically, biopharmaceuticals are derived from biological sources, including tissues, cells, or microorganisms. Biopharmaceuticals comprise a wide extent of therapies, such as vaccines, monoclonal antibodies, cell therapies, recombinant proteins, and gene therapies, as well as biosimilars. These products are designed to become important treatment options for different diseases, including cancer, autoimmune pathological disorders, andinfectious diseases. The development of biopharmaceuticals often includes multifaceted processes, involving genetic engineering and cellular culture techniques, to guarantee efficacy and safety. Accordingly, biopharmaceuticals’ legislation is a key component for ensuring the highest quality of medical products, as well as protecting public health. As a rapidly developing area inside the pharmaceutical industry, biopharmaceuticals represent a significant advancing stage in modern medicine, offering targeted therapies that can improve patient outcomes. Accordingly, this paper seeks to provide current state-of-the-art didactic information, including better insight into various challenges related to biopharmaceuticals’ development, classification, medical use, legislation and ethics....
Background/Objectives: To evaluate the real-world efficacy and safety of switching from adalimumab originator (Humira®, AbbVie) to SB5 biosimilar (Adalloce®, Samsung Bioepis) in patients with noninfectious uveitis. Methods: This retrospective study included 18 patients (32 eyes) who switched from adalimumab originator to SB5 for nonmedical reasons with at least 6 months follow-up. Clinical outcomes—best-corrected visual acuity (BCVA), intraocular pressure (IOP), anterior chamber (AC) cell grade, vitreous haze grade, central macular thickness (CMT), and macular volume (MV)—were assessed at baseline and 2, 4, and 6 months post-switch. Ultra-widefield fluorescein angiography (UWFA) findings were compared at approximately 4 months. Pre- versus post-switch comparisons employed Wilcoxon signed-rank tests. Results: Mean patient age was 45.7 ± 13.4 years, with mean follow-up of 16.8 ± 5.9 (range, 9–29) months. No significant changes were observed in BCVA, IOP, AC cell grade, vitreous haze grade, CMT, or MV at any timepoint versus baseline (all p > 0.05). No uveitis recurrence occurred based on predefined criteria including AC cell grade, vitreous haze grade, BCVA, and UWFA findings. Five patients (28%) re-switched to the originator after a mean of 24 (range, 4–64) weeks due to injection-site discomfort (n = 2) or extremity rashes (n = 3). No other adverse events were observed. Conclusions: Switching from adalimumab originator to SB5 biosimilar maintained clinical stability with comparable efficacy and safety in patients with noninfectious uveitis, supporting its use as a cost-effective alternative....
Background/Objectives: Biologic therapies have transformed the management of inflammatory bowel disease (IBD), but their high cost has prompted the introduction of biosimilars. Although switching from biologic originators to biosimilars is increasingly common, real-world evidence remains limited. We aimed to explore the safety and efficacy of switching between biologic originators and biosimilars. Methods: We conducted a retrospective chart review of patients with IBD between 2015 and 2025. Adult patients receiving adalimumab-adaz or adalimumab-atto were included. Patients who were non-medically switched once from adalimumab originator (Humira®) to any biosimilar were classified as group A. Patients who also switched back to originator (multiple switches) were classified as group B. The outcomes of the study were safety and efficacy of the biosimilars. Logistic regression identified switching predictors. Results: A total of 237 patients were included in the study. The number of patients in group A and group B was 208 and 58 patients, respectively. Sustained clinical remission was achieved in 198 (95.4%) of group A and 54 (93.6%) of group B participants. Sustained normalization of inflammatory markers was also comparable, occurring in 190 (91.5%) of group A and 54 (92.3%) of group B participants. No treatment-emergent AEs, infections, or treatment discontinuations were reported in either group (0%). Regression analysis identified older age and prior immunomodulator use as significant predictors of switching. Conclusions: Multiple switches of adalimumab biosimilars can be safely undertaken without increasing the risk of adverse reactions or treatment failure. This study provides meaningful evidence to guide policy and physician confidence in biosimilar interchangeability as a sustainable IBD therapeutic strategy....
Background/Objectives: Intravitreal anti–vascular endothelial growth factor (anti-VEGF) therapy is the standard treatment for neovascular age-related macular degeneration (nAMD), but concerns remain regarding its potential effects on optic nerve structure. Evidence on the structural safety of ranibizumab biosimilars, including LucenBS®, is still limited. This study aimed to investigate the short-term effects of intravitreal LucenBS® injections on peripapillary retinal nerve fiber layer (RNFL) thickness in previously treated nAMD patients using optical coherence tomography (OCT). Methods: This retrospective, observational case series included 24 eyes from 24 nAMD patients who had previously received anti-VEGF agents other than ranibizumab biosimilar. In bilateral cases, the eye that developed nAMD earlier was selected. Patients received between one and three LucenBS® injections, and the mean follow-up period after the final injection was 11.92 ± 4.81 weeks. Best-corrected visual acuity (BCVA), intraocular pressure (IOP), central macular thickness (CMT), and peripapillary RNFL thickness were assessed before and after each injection using spectral-domain OCT. Sectoral and global RNFL values were compared using the Wilcoxon signed-rank test. Results: The mean age of participants was 74.6 ± 9.0 years, and baseline BCVA and IOP were 0.83 ± 0.66 logMAR and 14.88 ± 2.80 mmHg, respectively. RNFL thickness showed no significant changes in either global or sectoral regions after any injection (all p > 0.05). CMT significantly decreased after the first injection (p = 0.007), but remained stable with subsequent treatments. BCVA remained stable after the first and second injections, but slightly worsened after the third injection (p = 0.012). IOP showed no significant changes at any time point. Conclusions: Short-term intravitreal LucenBS® injections did not induce structural alterations in the peripapillary RNFL, supporting their short-term ocular safety in previously treated nAMD patients. Although CMT improved after the first injection, functional and anatomical responses varied with repeated dosing. Larger, long-term studies are required to further validate the structural and functional safety of ranibizumab biosimilars in nAMD management....
Background: Sintilimab plus a Bevacizumab biosimilar (IBI305) is an approved first-line regimen for unresectable hepatocellular carcinoma (uHCC) in China. However, data on its safety and efficacy in patients with impaired liver function remain limited. We assessed the clinical outcomes of this combination therapy in HCC patients with Child-Pugh class A (CP-A) and class B (CP-B) liver function. Methods: In this multicenter retrospective cohort study, 99 patients with advanced uHCC (73 CP-A; 26 CP-B) who received first-line Sin/Bev were included. Tumor response was assessed using modified RECIST criteria, and adverse events (AEs) were graded per CTCAE v5.0. Survival outcomes, including overall survival (OS), progression-free survival (PFS), and time to hepatic decompensation (TTD), were analyzed via Kaplan-Meier estimates and Cox proportional hazards models. Results: The objective response rates (ORR) of patients with CP-A and CP-B treated with Sin/Bev were 50.7% and 57.7%, respectively, and both could achieve good anti-tumor efficacy. CP-B had inferior survival: median OS (15 vs 22 months, p=0.044), PFS (8 vs 14 months, p=0.014), and TTD (7 vs 15 months, p<0.001). The CP-B cohort demonstrated comparable incidence rates of grade 3–4 AEs to the CP-A group (34.6% vs 34.2%). Hemorrhagic events and thrombocytopenia emerged as predominant grade 3–4 AEs in CP-B patients (15.4% for both). Conclusions: Sin/Bev demonstrated encouraging short-term anti-tumor activity in HCC of CP-A and CP-B, while survival outcomes were affected by differences in hepatic function. Although the regimen was generally well tolerated, patients with impaired liver reserve require vigilant monitoring and comprehensive supportive strategies to maximize therapeutic outcomes....
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