Razumab (ranibizumab biosimilar) / Intas - LARVOL DELTA

Biosimilar Versus Innovator Ranibizumab in Myopic CNVM: Comparative Real-World Outcomes- The BRIM Study. (PubMed, Clin Ophthalmol) - "To compare the efficacy and safety of biosimilar ranibizumab (Razumab®) versus innovator ranibizumab (Lucentis®/Accentrix®) in the treatment of myopic choroidal neovascular membrane (mCNVM). IOP remained stable in both cohorts, and no significant ocular or systemic adverse events were observed. Biosimilar ranibizumab demonstrated non-inferior visual and anatomical outcomes compared to innovator ranibizumab in the treatment of mCNVM, with a similar safety profile and treatment burden."

Clinical • Journal • Real-world evidence • Ophthalmology

CompaRative Safety Analysis of Innovator and BioSimilar Ranibizumab in Chorioretinal Vascular Diseases - The CRsIBS Study. (PubMed, Clin Ophthalmol) - "To compare the safety profiles of biosimilar ranibizumab (Razumab™) and innovator ranibizumab (Accentrix™) in the management of chorioretinal vascular diseases across a large, diverse patient cohort in a multicenter retrospective study...This large-scale real-world study demonstrates that biosimilar ranibizumab offers a comparable safety profile to innovator ranibizumab in the management of chorioretinal vascular diseases. The affordability of biosimilar ranibizumab enhances its potential as a cost-effective alternative, particularly in resource-limited settings, without compromising safety."

Journal • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Hematological Disorders • Inflammation • Macular Degeneration • Myocardial Infarction • Ocular Infections • Ocular Inflammation • Ophthalmology • Pain • Retinal Disorders • Retinal Vein Occlusion

Comparing safety and efficacy of Bevacizumab, Ranibizumab and Ranibizumab biosimilar in Retinopathy of prematurity. (PubMed, Eye (Lond)) - "All three drugs were similar in their efficacy and safety profile with bevacizumab showing a later reactivation."

Journal • Cataract • Inflammation • Ophthalmology • Retinal Disorders • Retinopathy of Prematurity

Innovator ranibizumab ComparEd to Biosimilar ranibizumab in combination with Expansile gas in submaculaR HemorrhaGe: the ICEBERG study. (PubMed, BMC Ophthalmol) - "Biosimilar RBZ may act as a viable alternative to innovator RBZ to treat SMH with comparable anatomical and visual outcomes at 6 months."

Clinical • Journal • Retrospective data • Age-related Macular Degeneration • Hematological Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Transitioning from Aflibercept to Biosimilar Ranibizumab in Diabetic Macular Edema (DME): (The TRANSFORM-DME Trial) a Multicenter Observational Study. (PubMed, Clin Ophthalmol) - "Transitioning to biosimilar Ranibizumab (Razumab) after initial treatment with aflibercept in patients with DME preserved visual and anatomical benefits over a 12-month period, with only minor variations in SRF and IRF. These results underscore the efficacy of biosimilar Ranibizumab as a cost-effective option for managing DME."

Journal • Observational data • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Punctate inner choroiditis and choroidal neovascular membrane formation following vitreoretinal surgery: A case report. (PubMed, Eur J Ophthalmol) - "This case underscores the importance of long-term follow-up and timely intervention in managing PIC, especially in high myopes post-retinal surgery. Early identification and treatment with systemic corticosteroids and anti-VEGF therapy are crucial to preserving visual function and preventing severe complications like CNVM."

Journal • Surgery • Cataract • Ocular Inflammation • Ophthalmology • Retinal Disorders

Ranibizumab Biosimilars in Treating Retinal Disorders: A Cost-Effective Revolution? (PubMed, Drug Des Devel Ther) - "Since the approval of the first biosimilar Razumab, there has been a variety of new biosimilars available on the market. In conclusion, ranibizumab biosimilars offer a promising avenue for the management of retinal diseases, especially in countries with lower socioeconomic status, where there is lack of availability of innovator ranibizumab. However, further research is required to fully explore their efficacy, safety, and long-term outcomes in a plethora of retinal diseases."

Cost effectiveness • HEOR • Journal • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Retinopathy of Prematurity • Wet Age-related Macular Degeneration • VEGFB

Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence. (PubMed, Clin Ophthalmol) - "To analyse outcomes of innovator ranibizumab (IRM) (Lucentis) and biosimilar ranibizumab (BRM) (Razumab) in Indian eyes with neovascular age-related macular degeneration (nAMD). A similar profile of adverse events was noted in both the groups. Intravitreal injection of IRM and BRM show similar efficacy and safety in Indian eyes with nAMD."

HEOR • Journal • Real-world • Real-world evidence • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Efficacy of a biosimilar ranibizumab monotherapy for the treatment of retinopathy of prematurity. (PubMed, Indian J Ophthalmol) - "The cumulative incidence of recurrence of neovascularization (21%, 95% CI = 14%-29%) peaked at seven weeks and was significantly higher in eyes with APROP (43%, 95% CI = 27%-63%) compared to eyes without APROP (13.4%, 95%CI, 8%-22%) (P < 0.001). Razumab appears to be safe and effective in treating ROP, with about a third requiring reinjection at seven weeks after the first dose."

Journal • Monotherapy • Retrospective data • Retinal Disorders • Retinopathy of Prematurity

The Effects of Combuxil and Leizumab on Retinal Function and Serum Interleukin-17A in Premature Infants with Retinopathy. (PubMed, Comput Math Methods Med) - "Intravitreal injection of razumab is an effective treatment for retinopathy of prematurity, which can effectively improve the retinal function of infants. The level of serum interleukin-17A can be reduced and intraocular pressure can be regulated, which is safe and effective."

Journal • Hematological Disorders • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinopathy of Prematurity • IL17A

Innovator Versus Biosimilar Ranibizumab in Polypoidal Choroidal Vasculopathy: Real-World Evidence. (PubMed, Ophthalmol Ther) - "Our real-world data demonstrated the ranibizumab biosimilar Razumab to have comparable visual acuity outcomes to the innovator ranibizumab molecule with an adequate safety profile in the management of PCV. Although these encouraging results support its use as a viable alternative to the innovator molecule, further prospective studies in a diverse patient population are needed to validate our findings."

HEOR • Journal • Real-world evidence • Age-related Macular Degeneration • Ocular Inflammation • Ophthalmology • Uveitis

Comparison of Innovator vs. Biosimilar Ranibizumab in Treating Diabetic Macular Edema: A Multicenter Retrospective Study. (PubMed, Ophthalmol Ther) - "Biosimilar RBZ is similar to innovator RBZ in improving vision and reducing CMT in eyes with DME in the short term."

Journal • Retrospective data • Diabetic Macular Edema • Ophthalmology

Already seen [Google Translation] (Retina Today) - "When Retina Today launched 15 years ago, the anti-VEGF era was in its infancy, with the first intraocular agent, pegaptanib...gaining approval just 2 years prior...Everyone who was practicing at the time will never forget the excitement-and relief-we felt to finally have access to approved therapies that made a real difference for our patients with macular degeneration."

Media quote

Pipeline therapies for neovascular age related macular degeneration. (PubMed, Int J Retina Vitreous) - "Prior treatments have included focal laser therapy, verteporfin (Visudyne, Bausch and Lomb, Rochester, New York) ocular photodynamic therapy, transpupillary thermotherapy, intravitreal steroids and surgical excision of choroidal neovascular membranes. Currently, the major therapies in AMD focus on the VEGF-A pathway, of which the most common are bevacizumab (Avastin; Genentech, San Francisco, California), ranibizumab (Lucentis; Genentech, South San Francisco, California), and aflibercept (Eylea; Regeneron, Tarrytown, New York)...Cheaper alternatives, including ranibizumab biosimilars, include razumab (Intas Pharmaceuticals Ltd., Ahmedabad, India), FYB 201 (Formycon AG, Munich, Germany and Bioeq Gmbh Holzkirchen, Germany), SB-11 (Samsung Bioepsis, Incheon, South Korea), xlucane (Xbrane Biopharma, Solna, Sweden), PF582 (Pfnex, San Diego, California), CHS3551 (Coherus BioSciences, Redwood City, California). Additionally, aflibercept biosimilars under development include..."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

[VIRTUAL] Unique Case of Choroidal Detachment after Intravitreal Razumab (APAO 2021) - No abstract available

Clinical • Ophthalmology

Razumab -- the role of biosimilars for the treatment of retinal diseases. (PubMed, Drugs Today (Barc)) - "Clinical and preclinical studies have shown a favorable efficacy and safety profile of Razumab. Nonetheless, even if clinical equivalence is expected, randomized controlled clinical trials are needed to directly compare Razumab with the innovator ranibizumab in different retinal diseases."

Clinical • Journal • Ophthalmology • Retinal Disorders

Ranibizumab Biosimilar (Razumab) vs Innovator Ranibizumab (Lucentis) in neovascular age-related macular degeneration (n-AMD)- efficacy and safety (BIRA study). (PubMed, Eye (Lond)) - No abstract available

Clinical • Journal • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Treatment Landscape of Macular Disorders in Indian Patients with the Advent of Razumab™ (World's First Biosimilar Ranibizumab): A Comprehensive Review. (PubMed, Ophthalmol Ther) - "The safety profile of Razumab is comparable to that of the innovator ranibizumab and is well tolerated without any new safety concerns. Here, we review the clinical and real-world data of Razumab in the treatment of macular disorders."

Clinical • Journal • Review • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Visual outcomes, safety profile and morphometric response of optical coherence tomography biomarkers to ranibizumab biosimilar treatment in neovascular age-related macular degeneration: Real-world evidence. (PubMed, Indian J Ophthalmol) - "In real-world scenario, Razumab is an efficacious and economical anti-vascular endothelial growth factor (anti-VEGF) agent for optimal management of n-AMD. The therapeutic outcomes demonstrated reasonable stabilization and improvement in visual acuity, favorable anatomical outcomes pertaining to OCT-biomarkers with an acceptable safety profile."

Biomarker • Clinical • HEOR • Journal • Real-world evidence • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Real-World Safety Outcomes of Intravitreal Ranibizumab Biosimilar (Razumab) Therapy for Chorioretinal Diseases. (PubMed, Ophthalmol Ther) - "The study reports the largest pooled safety data on IVRz use in a real-world scenario. The results did not raise any new ocular or systemic safety concerns for the biosimilar agent, with the incidence and spectrum of adverse reactions similar to those reported with other anti-vascular endothelial growth factor (anti-VEGF) drugs. The real-world evidence suggests that IVRz is a safe anti-VEGF agent in the management of chorioretinal disorders."

Clinical • Journal • Real-world evidence • Cardiovascular • Hematological Disorders • Myocardial Infarction • Ocular Infections • Ocular Inflammation • Ophthalmology • Pain

Safety and efficacy of Razumab™ (world’s first biosimilar ranibizumab) in wet age-related macular degeneration: a post-marketing, prospective ASSET study. (PubMed, Int J Retina Vitreous) - "Razumab™ (world's first biosimilar ranibizumab) was well-tolerated without new safety concerns and significantly improved visual acuity in wet AMD patients. Trial registration CTRI/2016/03/006739."

Clinical • Journal • P4 data • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab. (PubMed, Indian J Ophthalmol) - ": Razumab® showed a rapid improvement in CDVA and CFT in most of the eyes with efficacy observed as early as 1 month and maintained till 3 months. The biosimilar Ranibizumab can be a safe and effective low-cost drug for treating macular diseases."

Clinical • Journal • Diabetic Macular Edema • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Retinal Vein Occlusion

Changing trends in the use of anti-vascular endothelial growth factor (anti-VEGF) biosimilars: Insights from the Vitreoretinal Society of India Biosimilars of Anti-VEGF Survey. (PubMed, Indian J Ophthalmol) - "One-third of the participants deem the current price of ranibizumab-biosimilar as appropriate to replace Avastin. Simultaneously, the need for enhanced pharmacovigilance and larger clinical trials are warranted for regulatory approval of these agents."

Journal

Biosimilars for Retinal Diseases: An Update. (PubMed, Am J Ophthalmol) - "Biosimilars hold the potential to reduce the financial burden of the highly efficacious biologic therapy in retinal pathologies. However, the off label bevacizumab may differentiate the success of biosimilars in different geographic regions."

Journal • Review • Ophthalmology • Retinal Disorders

A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion. (PubMed, Ophthalmol Ther) - "Biosimilar ranibizumab demonstrated improvements in visual acuity and disease outcomes up to 48 weeks in patients with RVO without any new safety concerns."

Journal • Retrospective data • Diabetic Macular Edema • Retinal Vein Occlusion