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Biosimilar ranibizumab (Epruvy)

✓ Approved

Midas Pharma · VEGFA · 单克隆抗体

什么是 Biosimilar ranibizumab？

Biosimilar ranibizumab 是一种单克隆抗体，由Midas Pharma研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)。

药物档案

商品名Epruvy
公司Midas Pharma
药物类别单克隆抗体, 抗体
分子靶点VEGFA
给药途径Injectable (Others)
状态Approved
来源： ClinicalTrials.gov, Midas Pharma

作用机制

分子靶点

Biosimilar ranibizumab 作用于 1 个分子靶点：

VEGFAvascular endothelial growth factor A (VPF, MVCD1)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

Biosimilar ranibizumab 针对 4 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Eye disordersDiabetic retinal oedema✓ Approved
Eye disordersGlaucoma✓ Approved
Eye disordersCystoid macular oedema✓ Approved
Eye disordersNeovascular age-related macular degeneration✓ Approved

相关研究文献

PubMedRevista espanola de enfermedades digestivas2026-10-26

Biosimilars in inflammatory bowel disease: from initial uncertainty to clinical normalization.

Argüelles-Arias Federico F, Zabana Yamile Y

Biosimilars have become an integral part of the treatment of inflammatory bowel disease (IBD), evolving from initial uncertainty regarding indication extrapolation and non-medical switching to widespread clinical acceptance. Early concerns focused mainly on the absence of disease-specific evidence and the potential impact of switching on effectiveness, safety, and immunogenicity. Over the past decade, however, extensive real-world evidence and randomized data have consistently supported the use of infliximab and adalimumab biosimilars in both biologic-naïve patients and patients switched from originator products. Recent systematic reviews and meta-analyses further reinforce these findings, showing preserved clinical remission, treatment persistence, inflammatory biomarkers, and immunogenicity after switching. The biosimilar landscape is now expanding to newer therapeutic targets, including ustekinumab, while biosimilar-to-biosimilar and multiple switching is becoming increasingly relevant in routine practice. Nevertheless, scientific interchangeability should not be equated to automatic substitution. Switching decisions should remain clinically supervised and involve gastroenterologists within a multidisciplinary framework, taking into account disease activity, previous response, safety, immunogenicity, and patient preferences. Appropriate communication is also essential to minimize a potential nocebo effect and to avoid unnecessary discontinuation. Biosimilars should therefore be considered fully established biological therapies rather than lower-tier alternatives to originator drugs. Future research should focus less on re-confirming single-switch equivalence and more on unresolved questions, including long-term outcomes after multiple switching, biosimilars of newer therapeutic targets, patient-reported outcomes, treatment persistence, and comparative pharmacoeconomic impact across healthcare systems.

PMID 42929266
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PubMedBiotech (Basel (Switzerland))2026-10-26

Analytical Characterization, Pharmacokinetics, Safety, and Preliminary Immunogenicity of GNR-062, an Agalsidase Beta Biosimilar Candidate, in Healthy Male Volunteers.

Lyagoskin Ivan I, Smolov Maksim M, Markova Oksana O, Klyashtorny Vladislav V et al.

Fabry disease is a rare genetic multisystemic lysosomal disease characterized by progressive cellular accumulation of globotriaosylceramide (GL-3) in various organs with specific cutaneous (angiokeratoma), neurological (pain), renal (proteinuria, chronic kidney failure), cardiovascular (cardiomyopathy, arrhythmia), cochleovestibular and cerebrovascular manifestations (transient ischemic attacks, strokes). The phenotypic expression depends on the age of onset and, in females, on the level of X-inactivation. Enzyme replacement therapy is currently the standard therapy for the disease. JSC GENERIUM recently developed a potential biosimilar of Fabrazyme®, GNR-062, and investigated its physicochemical and biological properties, pharmacokinetics and immunogenicity to assess its bioequivalence to Fabrazyme®. Direct evaluation of the N-glycosylation profile by HPLC revealed differences mainly related to the distribution of complex sialylated glycans. The overall sialylation level was comparable between the two products. The same conclusion follows from the results of direct analysis of the sialic acid content. Despite a small difference of a few percent in biphosphorylated glycan content, the overall measured M6P values were comparable. Thus, the internalization of agalsidase β into the inner space of lysosomes by binding to key receptors appear to be the same for both products. In a single-blind, randomized comparative study of the pharmacokinetics and safety of a single intravenous infusion of GNR-062 (JSC GENERIUM, Russia) and Fabrazyme® (Genzyme Europe B.V., The Netherlands) in a crossover design in healthy volunteers, the ratio of geometric means (90% CI) of AUCinf and Cmax for GNR-062 to agalsidase β was 0.9736 (0.9413-1.0070) and 0.9867 (0.9546-1.0199), respectively. These studies demonstrated pharmacokinetic bioequivalence of GNR-062 to agalsidase β. Immunogenicity findings are preliminary, as the study was not powered for formal immunogenicity equivalence, and the single-dose design in healthy volunteers does not reflect repeated long-term administration in patients with Fabry disease. In conclusion, GNR-062 demonstrated acceptable short-term tolerability in healthy volunteers and warrants further investigation as a potential therapeutic option for patients with Fabry disease.

PMID 42930071
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PubMedClinics and practice2026-10-26

Physiotherapy Interventions for Migraine: A Systematic Review of Clinical Trials.

Strachanowska Helena Małgorzata HM, Kaczmarska Martyna Anna MA, Robakowska Marlena M, Brancewicz Michał M

Background: Migraine is one of the leading causes of disability worldwide and significantly reduces quality of life. Standard pharmacological treatment is often associated with adverse effects and does not always provide satisfactory long-term outcomes. Consequently, increasing attention has been directed toward non-pharmacological interventions such as physiotherapy. The aim of this systematic review was to evaluate the effectiveness of physiotherapy used as a standalone or complementary treatment for migraine. Methods: A systematic review of randomized controlled trials (RCTs) published between 2015 and 2025 was conducted in accordance with PRISMA 2020 guidelines. Electronic databases (PubMed, Cochrane Library, Scopus and PEDro) were searched using predefined search strategies. Studies involving adults diagnosed with migraine who received physiotherapy interventions (e.g., manual therapy, exercise therapy) were included. Two reviewers independently screened records and extracted data. Methodological quality of included studies was assessed using the PEDro scale. Results: Thirteen clinical trials (including 12 RCTs) involving 1021 participants were included. The most frequently investigated interventions were manual therapy and exercise therapy. Improvements in at least one primary clinical outcome (migraine frequency, pain intensity, or disability scores such as MIDAS or HIT-6) were observed in 8 out of 13 studies. A reduction in migraine frequency was reported in 4 studies. However, results were inconsistent across trials, and several studies found no statistically significant differences between the intervention and control groups. Conclusions: Physiotherapy may represent a beneficial complementary approach in migraine management, particularly for improving pain intensity and disability outcomes. However, the available evidence is limited by significant heterogeneity in intervention protocols, outcome measures, and follow-up duration, as well as the lack of quantitative synthesis. Further high-quality randomized trials with standardized methodology and longer follow-up periods are required to strengthen the evidence base.

PMID 42930377
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PubMedJournal of managed care & specialty pharmacy2026-10-25

Comparing prescribing and spending across originator, follow-on, and interchangeable biosimilar insulin glargine: Opportunities to improve uptake of biosimilar medications.

Abrams Lucille M LM, Funk Kylee K, Farley Joel F JF

Administrative barriers (eg, prior authorizations, slow reimbursement, and poor communication between providers and payers) and inconsistency regarding cost savings are potentially slowing the acceptance of biosimilar medications by providers and patients. In this study, we used the example of interchangeable biosimilar insulin glargine, the first-ever interchangeable biosimilar approved by the US Food and Drug Administration in 2021, as a case study to discuss the potential challenges and benefits of biosimilars. To describe trends in market share and spending for originator, follow-on, and biosimilar insulin glargine products and to discuss the potential benefits and challenges of biosimilars for providers and patients and whether the introduction of these products lowers insulin glargine costs for payers and members in Minnesota. This retrospective descriptive study evaluated prescribing and cost data for insulin glargine, using pharmacy claims data from the Minnesota All Payer Claims Database for 2015-2023, including claims from commercial and public payers (ie, Medicare and Minnesota Health Care Programs). Yearly totals of filled prescriptions and average payer and member per-prescription costs were used to construct trends. Prescription volume for originator insulin glargine steadily decreased by 58.9% across all payers from 2015 to 2018, whereas prescriptions for the follow-on product increased from 32 to 167,052 total prescriptions between 2016 and 2018. Biosimilar prescribing grew from 0.3% of all insulin glargine prescribed in 2021 to 8.3% in 2023. When compared with the originator medication, follow-on and biosimilar insulin glargine provided consistent reduced claims payments to all payers and inconsistent cost savings to members. Although payers experience consistently reduced claims-based spending from biosimilar and follow-on insulin glargine compared with originator insulin glargine, inconsistent patient cost savings are a missed opportunity to improve affordability for cost-burdened patients. Additionally, until administrative barriers are resolved, providers may be less inclined to consistently prescribe biosimilars. Both issues may contribute to the slow, uneven uptake of biosimilars, and policymakers should incentivize both commercial and public payers to favor biosimilar prescribing, reduce barriers to prescribing, and ensure that cost savings are passed on to patients.

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PubMedClinical & experimental optometry2026-10-25

Development full-thickness macular hole and exudative retinal detachment in central retinal vein occlusion after intravitreal ranibizumab.

Yang Yi Y

Intravitreal injection of anti‑vascular endothelial growth factor (VEGF) has become a first-line treatment for macular oedema secondary to central retinal vein occlusion (CRVO). However, there have been recent reports of a surprising complication associated with intravitreal injection of anti-VEGF. We report a case of full-thickness macular hole (FTMH) and exudative retinal detachment (ERD) after intravitreal injection of ranibizumab for macular oedema. A 21-year-old patient with macular oedema secondary to CRVO developed FTMH and ERD in her left eye after the first intravitreal injection of ranibizumab. A 25 G vitrectomy was performed, during which the internal limiting membrane was peeled off followed by filling with silicone oil tamponade. One week after the operation, optical coherence tomography showed closure of the macular hole. Although vitrectomy combined with removal of the inner limiting membrane can reclose macular hole caused by intravitreal injection of anti-VEGF drugs, these cases of FTMH differ from those of idiopathic FTMH in having a poorer visual prognosis. Ophthalmologists should be vigilant in monitoring the possibility of inducing macular hole through treatment with ranibizumab. In addition, ERD associated with CRVO represents a serious vision-threatening complication that merits close clinical attention from ophthalmologists.

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PubMedNeuroepidemiology2026-10-25

Implementing the National Alzheimer's Coordinating Center Uniform Data Set (v3) within the Diabetes Prevention Program Outcomes Study.

Doherty Lindsay Kathleen LK, Dechiario Isabella I, Sherif Hanna H, Bowers Anna A et al.

The Diabetes Prevention Program (DPP) was a randomized clinical trial designed to prevent type 2 diabetes (T2D) in adults with prediabetes. The DPP Outcomes Study (DPPOS) is the 30-year follow-up of this cohort, focusing on T2D, prediabetes, and related complications. Cognitive assessments began in 2009 and expanded in 2022 to examine cognitive impairment, including Alzheimer's disease (AD) and AD related dementias (ADRD), in the surviving cohort. To support these aims, the National Alzheimer's Coordinating Center Uniform Data Set version 3 (NACC-UDSv3), the standardized framework used by Alzheimer's Disease Research Centers, was implemented in DPPOS in 2022 to enable data sharing with NACC. These forms were complemented by cognitive tests administered in DPPOS. We aimed to integrate the NACC-UDSv3 into the existing longitudinal DPPOS framework while maintaining fidelity to its structure and developing automated reports to streamline cognitive outcomes adjudication. Items from the 16 NACC-UDSv3 data forms were compared with those already collected within DPPOS to integrate overlapping similar items, add missing NACC-UDSv3 items, and create a dataset harmonized with NACC-UDSv3. Forms were adapted for electronic data capture (EDC) using the MIDAS (Multimodal Integrated Data Acquisition System, George Washington University). Automated reports integrated current and prior neuropsychological scores to support adjudications. In the first wave of the DPPOS-AD/ADRD study, 1561 cognitive adjudications were successfully completed using the harmonized DPPOS and NACC-UDSv3 data implemented into MIDAS. The DPPOS-AD/ADRD project demonstrated that NACC-UDSv3 can be successfully integrated into a long-standing longitudinal cohort not originally designed for AD/ADRD research. The harmonization, electronic capture, and automated adjudication processes may provide a practical framework for other cohorts seeking to incorporate NACC-UDSv3 to align with national AD/ADRD research standards.

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