Pavblu (aflibercept-ayyh) / Amgen - LARVOL DELTA

PAVBLU (aflibercept-ayyh) sales increased 121% year-over-year to $287 million in the second quarter, primarily driven by volume growth based on its position as the only commercially available biosimilar to EYLEA in the U.S. during this period. (PRNewswire)

Sales • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=304 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Real-World Utilization and Initial Experience with Aflibercept-ayyh (PAVBLU®) for Retinal Disorders in United States Retina Practices: A Descriptive Retrospective Analysis. (PubMed, Ophthalmol Ther) - "In this descriptive real-world analysis, aflibercept-ayyh was associated with stable visual acuity in previously treated eyes and vision improvement in treatment-naïve eyes, with no new or unexpected safety findings, consistent with expectations for aflibercept and the established body of evidence supporting biosimilarity between aflibercept-ayyh and reference aflibercept, EYLEA®)."

Journal • Real-world evidence • Retrospective data • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Hematological Disorders • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Uveitis • Vasculitis • Wet Age-related Macular Degeneration

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=304 | Not yet recruiting | Sponsor: Amgen

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Real-World Evidence From 1,000 Eyes Treated With Aflibercept-ayyh (Pavblu): Safety and Early Vision Outcomes. (ARVO 2026) - "Purpose To describe the real-world demographics, utilization, safety outcomes and visual acuity outcomes among the first 1,000 patient eyes treated with Pavblu, a biosimilar to aflibercept, for neovascular age-related macular degeneration (nAMD), diabetic retinopathy (DR), diabetic macular edema (DME), or retinal vein occlusion (RVO) within a large retina network in the United States (U.S). Two AESIs, both uveitis (iritis), occurred among 3,730 injections, with no instances of endophthalmitis, retinal detachment, vasculitis, or vitreous hemorrhage observed. Conclusions These early data suggest that aflibercept-ayyh (Pavblu) is a well-tolerated and effective biosimilar treatment option for nAMD, DR, DME and RVO."

Clinical • HEOR • Real-world • Real-world evidence • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Uveitis • Wet Age-related Macular Degeneration

Intraocular Pressure after Switch to High-Dose Aflibercept in Treatment-Experienced Patients with Neovascular Age-Related Macular Degeneration (ARVO 2026) - "Prior therapy included standard dose aflibercept 2 mg (SDA; 82.4%), aflibercept-ayyh 2 mg (5.9%), off-label bevacizumab 1.25 mg (5.9%), and faricimab 6 mg (5.9%)...Importantly, pressure remained stable, with no indication of elevation or increased variability, and the difference in pressure between the treated and fellow eye did not change. These findings indicate that high-dose aflibercept can extend treatment intervals without measurable pressure-related risk, supporting its safety profile in treatment-experienced patients."

Clinical • Age-related Macular Degeneration • Glaucoma • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis • Wet Age-related Macular Degeneration

PAVBLU (aflibercept-ayyh) generated $280 million in the first quarter. (Amgen Press Release)

Sales • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Uveitis • Wet Age-related Macular Degeneration

Aflibercept-ayyh (aflibercept 2 mg biosimilar) for treatment-naïve retinal vascular diseases: early real-world experience - the apex study. (PubMed, Expert Opin Biol Ther) - "To evaluate the early real-world efficacy of intravitreal aflibercept 2 mg biosimilar (aflibercept-ayyh, Pavblu, Amgen, U.S.A.) across common retinal vascular diseases in treatment-naïve eyes...No intraocular inflammation, vascular occlusion, endophthalmitis, or systemic adverse events occurred; cataract progression was observed in 0.7% of eyes. Aflibercept-ayyh demonstrated significant early visual and anatomical improvements across major retinal vascular diseases with a favorable short-term safety profile."

Journal • Real-world evidence • Cardiovascular • Cataract • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Vein Occlusion

Anti-Vascular Endothelial Growth Factor Biosimilars for Use in the Aging Eye. (PubMed, Drugs Aging) - "Several biosimilars for anti-VEGF drugs including bevacizumab, ranibizumab, and aflibercept are in various stages of development and approval (e.g. Afilivu, Yesafili, Enzeevu, Ahzantive, AVT-06, ABP 938, and ALT L9)...This review explores the current landscape of anti-VEGF biosimilars, their clinical efficacy, safety profiles, and the economic implications for treating the aging eye. It also addresses the challenges and future directions in the integration of biosimilars into routine ophthalmic practice."

Journal • Review • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Efficacy and safety of aflibercept biosimilars compared to aflibercept in the treatment of neovascular age-related macular degeneration: a systematic review and meta-analysis. (PubMed, Front Pharmacol) - "This study aimed to evaluate the aflibercept biosimilars compared to the reference product aflibercept (Eylea®) in terms of efficacy, safety, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD)...There were no statistically significant differences in visual and anatomical outcomes between the aflibercept biosimilars (SB15, P041, SDZ-AFL, AVT06, SCD411, ABP 938, and QL1207) and the reference aflibercept...Based on the seven included randomized controlled clinical trials, aflibercept biosimilars demonstrated comparable safety and efficacy to the reference aflibercept. Future research requires more rigorous studies."

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

Aflibercept 2 mg Biosimilar (aflibercept-ayyh, Pavblu): Experience of safety in clinical settings-APEX- safety study. (PubMed, Eye (Lond)) - No abstract available

Journal

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025 (European Medicines Agency) - "On 30 January 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pavblu, intended for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV)....Pavblu will be available as 40 mg/ml solution for injection in pre-filled syringe and vial."

CHMP • Diabetic Macular Edema • Ophthalmology • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Product Sales Performance (PRNewswire) - "Repatha (evolocumab) sales increased 44% year-over-year to $870 million in the fourth quarter...UPLIZNA (inebilizumab-cdon) sales increased 131% year-over-year to $233 million in the fourth quarter and 73% for the full year, primarily driven by volume growth...TEZSPIRE (tezepelumab-ekko) sales increased 60% year-over-year to $474 million in the fourth quarter...Otezla (apremilast) sales were flat year-over-year at $625 million in the fourth quarter...Enbrel (etanercept) sales decreased 48% year-over-year to $532 million in the fourth quarter...PAVBLU (aflibercept-ayyh) generated $258 million of sales in the fourth quarter and $700 million for the full year....WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $44 million of sales in the fourth quarter and $273 million for the full year."

Sales • Ankylosing Spondylitis • Asthma • Cardiovascular • Chronic Rhinosinusitis With Nasal Polyps • Crohn's disease • Diabetic Macular Edema • Diabetic Retinopathy • Familial Hypercholesterolemia • Immunology • Myasthenia Gravis • Neuromyelitis Optica Spectrum Disorder • Psoriasis • Psoriatic Arthritis • Retinal Vein Occlusion • Rheumatoid Arthritis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Inflammation (Amgen Press Release) - "TEZSPIRE (tezepelumab-ekko) sales increased 40% year-over-year to $377 million in the third quarter...Otezla (apremilast) sales increased 4% year-over-year to $585 million in the third quarter...Enbrel (etanercept) sales decreased 30% year-over-year to $580 million in the third quarter, primarily driven by 38% lower net selling price resulting from the impact of the U.S. Medicare Part D redesign and increased 340B Program mix, partially offset by favorable changes to estimated sales deductions and volume growth; AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales decreased 7% year-over-year to $154 million in the third quarter...PAVBLU (aflibercept-ayyh) generated $213 million of sales in the third quarter; WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $44 million of sales in the third quarter."

Sales • Ankylosing Spondylitis • Asthma • Crohn's disease • Diabetic Macular Edema • Diabetic Retinopathy • Immunology • Psoriatic Arthritis • Retinal Vein Occlusion • Rheumatoid Arthritis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Re: Friedman et al: Randomized Trial of Biosimilar ABP 938 Compared with Reference Aflibercept in Adults with Neovascular Age-Related Macular Degeneration (2025 Aug 5:S2468-6530(25)00351-3. doi: 10.1016/j.oret.2025.07.015. Online ahead of print.). (PubMed, Ophthalmol Retina) - No abstract available

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Randomized Trial of Biosimilar ABP 938 Compared with Reference Aflibercept in Adults with Neovascular Age-related Macular Degeneration. (PubMed, Ophthalmol Retina) - "This study supports a conclusion of no clinically meaning differences in efficacy, safety, and immunogenicity between ABP 938 and aflibercept RP in patients with nAMD. Additionally, transitioning from aflibercept RP to APB 938 at week 16 were comparable overall efficacy, safety, and immunogenicity to the continuous-treatment groups."

Journal • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

AMGEN REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS (Amgen Press Release) - "AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales were flat year-over-year at $133 million in the second quarter. PAVBLU (aflibercept-ayyh) generated $130 million of sales in the second quarter. WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $35 million of sales in the second quarter."

Sales • Crohn's disease • Idiopathic Arthritis • Inflammatory Bowel Disease • Psoriatic Arthritis • Ulcerative Colitis • Wet Age-related Macular Degeneration

Product Sales Performance (PRNewswire) - "Otezla (apremilast) sales increased 11% year-over-year to $437 million in the first quarter, driven by 12% favorable changes to estimated sales deductions, as volume growth of 4% was offset by 5% lower net selling price; Enbrel (etanercept) sales decreased 10% year-over-year to $510 million in the first quarter, driven by 47% lower net selling price resulting from increased 340B Program mix and higher commercial discounts, partially offset by 19% favorable changes to estimated sales deductions, higher inventory levels and volume growth...AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales decreased 19% year-over-year to $136 million in the first quarter, primarily driven by 33% lower net selling price, partially offset by 11% volume growth; WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $150 million of sales in the first quarter. WEZLANA launched in the U.S. in the first quarter of 2025....PAVBLU (aflibercept-ayyh) generated $99 million of sales in the first quarter."

Sales • Age-related Macular Degeneration • Ankylosing Spondylitis • Crohn's disease • Diabetic Macular Edema • Diabetic Retinopathy • Idiopathic Arthritis • Psoriasis • Psoriatic Arthritis • Retinal Vein Occlusion • Rheumatoid Arthritis • Ulcerative Colitis

Drugs for age-related macular degeneration. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product. (PubMed, Ophthalmol Ther) - "This integrated assessment of results from the in vitro pharmacology assessment and in vivo PK and TK/toxicology profiles formed the nonclinical portion of the totality of evidence demonstrating ABP 938 is a biosimilar to aflibercept RP."

Journal • Ophthalmology • Retinal Disorders

FDA Approves Pavblu for Retinal Conditions (MJH Life Sciences) - "The FDA has approved Pavblu (aflibercept-ayyh), the fifth biosimilar referencing Eylea (aflibercept).1 The new product is approved for the treatment of retinal conditions, including neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy....The approval was based on data from a randomized, double-masked, phase 3 study (NCT04270747) assessing the safety and efficacy of Pavblu (ABP 938) compared with Eylea in patients with wet AMD."

FDA approval • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product. (PubMed, Ophthalmol Ther) - "ABP 938 was structurally and functionally similar to aflibercept RP. Since aflibercept RP sourced from the US and EU were analytically similar, this allows for the development of a scientific bridge such that a single-source RP can be used in nonclinical and clinical studies."

Journal • Ophthalmology

AMGEN REPORTS THIRD QUARTER FINANCIAL RESULTS (Amgen Press Release) - "The FDA accepted the Biologics License Application for ABP 938, an investigational biosimilar to EYLEA (aflibercept)."

BLA • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

AMGEN REPORTS FIRST QUARTER FINANCIAL RESULTS (PRNewswire) - "The final analysis from a Phase 3 study evaluating the efficacy and safety of ABP 938, an investigational biosimilar to EYLEA® (aflibercept) compared with EYLEA in patients with neovascular age-related macular degeneration, is expected in H1 2023."

P3 data • Age-related Macular Degeneration • Ophthalmology

A Study to Evaluate ABP 938 and Aflibercept (Eylea®) in Participants With Chorioretinal Vascular Disease (CVD) (clinicaltrials.gov) - P3 | N=49 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed

Trial completion