Eydenzelt (aflibercept biosimilar) / Celltrion - LARVOL DELTA

Long-Term Efficacy and Safety of CT-P42 in Patients with Diabetic Macular Edema: 52-Week Results from a Phase 3 Randomized Clinical Trial. (PubMed, Ophthalmol Ther) - P3 | "Results through week 52 support the therapeutic equivalence between CT-P42 and reference aflibercept by demonstrating comparable long-term efficacy, safety, and immunogenicity."

Clinical • Journal • P3 data • Diabetes • Diabetic Macular Edema • Metabolic Disorders • Ophthalmology

Celltrion gains Australian approval for three biosimilars in ophthalmology and bone disease (Chosun Biz) - "Celltrion announced on the 10th that it received item approval from the Therapeutic Goods Administration (TGA) of Australia for its ophthalmic treatment 'Eydenzelt' (ingredient name: Aflibercept) and the bone disease treatments 'Stoboclo' and 'Osenvelt' (Denosumab)....'Eydenzelt' is a biosimilar of Regeneron's Eylea and is approved for the treatment of myopic choroidal neovascularization....'Stoboclo' is a biosimilar of Amgen's Prolia and is approved for postmenopausal women with osteoporosis. Similarly, 'Osenvelt', a biosimilar of Amgen's Xgeva, received approval for preventing skeletal-related complications in patients with bone metastatic cancer and all other treatment indications held by the original drug in Australia."

Approval • Ophthalmology • Osteoporosis

Celltrion, Eylea Biosimilar 'Eydenzelt' Approved in Europe [Google translation] (HIT News) - "Celltrion announced on the 14th that it had obtained product approval for 'EYDENZELT (development name: CT-P42),' a biosimilar of 'EYLEA,' from the European Commission (EC)....With this approval, two formulations, Eydenzelt Injection Vial and Eydenzelt Prefilled Syringe (PFS), have been secured, and approval has been granted for the same major indications as the original drug, including neovascular (wet) age-related macular degeneration (wAMD), retinal vein occlusion macular edema, diabetic macular edema (DME), and myopic choroidal neovascularization."

EMA approval • Diabetic Macular Edema • Macular Edema • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union (Businesswire) - "The Committee for Medicinal Products for Human Use (CHMP) adopts positive opinions for Celltrion’s three biosimilar candidates – Eydenzelt (aflibercept)...Eydenzelt (40 mg/mL solution for injection in vial and pre-filled syringe), a biosimilar to Eylea (aflibercept), is recommended for approval to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV)."

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

Eydenzelt (European Medicines Agency) - "...the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Eydenzelt, 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)."

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

Celltrion Announces Phase 3 52-Week Results of Eydenzelt at the European Society of Retina [Google translation] (Medipana) - P3 | N=348 | NCT04739306 | Sponsor: Celltrion | "Celltrion announced...that it had announced the 52-week results of the phase 3 global clinical trial of 'CT-P42 (product name: Eydenzelt),' a biosimilar to the ophthalmic treatment 'EYLEA (active ingredient: aflibercept),' at the European Society of Retina Specialists (EURETINA)....According to clinical results, the average change in best corrected visual acuity (BCVA) in both treatment groups steadily increased from baseline until week 16 and was maintained stably until week 52, proving the long-term therapeutic efficacy of CT-P42. In addition, similar results were confirmed in other secondary efficacy evaluation variables such as the average change in central retinal thickness and safety."

P3 data • Diabetic Macular Edema • Macular Edema • Ophthalmology

Celltrion Pharm's 3 biosimilars 24-36% cheaper than originals in Korea (Korea Biomedical Review) - "Celltrion Pharm said it has launched three biosimilar products in Korea following the Ministry of Health and Welfare’s pricing notification last Sunday....This biosimilar is prescribed for allergic asthma and chronic idiopathic urticaria, with reimbursed prices set at 102,960 won ($76.78) for the 75 mg dose and 195,079 won for the 150 mg dose— approximately 28 percent lower than the original product....The reimbursed price of the prefilled syringe (PFS) form will be available at 1,298,290 won for the 45 mg/0.5 mL dose and 1,342,320 won for the 90 mg/1 mL dose—about 26 percent less than the price of the original drug....Eydenzelt, approved in Korea in May, is indicated for the treatment of macular degeneration and visual impairment caused by macular edema due to retinal vein occlusion. The reimbursed price for the 11.32 mg/0.283 mL dose is set at 330,000 won, which is approximately 34 percent cheaper than the original product."

Reimbursement • Asthma • Crohn's disease • Immunology • Inflammatory Bowel Disease • Macular Degeneration • Macular Edema • Psoriasis • Psoriatic Arthritis • Retinal Vein Occlusion • Ulcerative Colitis

Biosimilar candidate CT-P42 in diabetic macular edema: 24-week results from a randomized, active-controlled, Phase III study. (PubMed, Ophthalmol Retina) - "This study in patients with DME demonstrated equivalence between CT-P42 and reference aflibercept (2 mg/0.05 mL) in terms of efficacy, with similar pharmacokinetic, usability, safety, and immunogenicity profiles."

Journal • P3 data • Diabetes • Diabetic Macular Edema • Diabetic Retinopathy • Metabolic Disorders • Ophthalmology • Retinal Disorders

Celltrion gains Korea approval of Eylea biosimilar (Bioworld) - "Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20."

Korea approval • Age-related Macular Degeneration • Diabetic Macular Edema • Ophthalmology • Wet Age-related Macular Degeneration

Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42 (ARVO 2024) - P3 | "This result supported the therapeutic equivalence between CT-P42 and AFL by demonstrating comparable efficacy and safety of CT-P42 compared to Eylea based on the 52-week data."

Clinical • P3 data • Diabetic Macular Edema • Ophthalmology

Celltrion confirms efficacy of Eylea biosimilar at EU meet (Korea Biomedical Review) - P3 | N=348 | NCT04739306 | Sponsor: Celltrion | "Celltrion said it confirmed the efficacy of CT-P42, a biosimilar referencing Eylea (ingredient: aflibercept), in a phase 3 study. The company presented the trial results during the FLORetina–ICOOR 2023 conference....In the clinical trial, Celltrion confirmed that the change in the best corrected visual acuity (BCVA) at 8 weeks for the CT-P42 group and the original drug group was within the equivalence range. The trial also showed similar results to the original drug in terms of other secondary efficacy evaluation variables up to 24 weeks, as well as safety and immunogenicity. Based on these phase 3 clinical trial results, Celltrion plans to accelerate the global market entry of CT-P42."

P3 data • Diabetic Macular Edema • Macular Edema • Ophthalmology

Celltrion’s Eylea biosimilar waits for EMA permission (Korea Biomedical Review) - "Celltrion said it recently submitted a marketing authorization application for CT-P42, an Eylea (aflibercept) biosimilar, to the European Medicines Agency (EMA). The application is for wet age-related macular degeneration (wAMD), cystoid retinal vein occlusive (CRVO-BRVO) macular edema, diabetic macular edema (DME), and choroidal neovascularization (CNV)....The company stated that plans for selling CT-P42 in the EU market will be finalized after obtaining marketing authorization....The application is based on phase 3 results of CT-P42..."

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

Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P3 | N=348 | Completed | Sponsor: Celltrion | Trial primary completion date: Jun 2022 ➔ Oct 2022

Trial primary completion date • Diabetic Macular Edema • Ophthalmology

Formycon and Celltrion Announce FDA Submission of aBLAs Seeking Approval to Market Aflibercept Biosimilars (JD Supra) - "Celltrion announced...that it has submitted an aBLA seeking approval to market its aflibercept biosimilar candidate, CT-P42, for the full range of non-pediatric approved indications of Eylea®. Celltrion indicated that submissions to regulatory authorities in Europe and other major economies are forthcoming."

BLA • Diabetic Macular Edema • Macular Edema • Ophthalmology • Retinal Disorders

Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P3 | N=348 | Completed | Sponsor: Celltrion | Active, not recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P3 | N=348 | Active, not recruiting | Sponsor: Celltrion | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2022 ➔ Apr 2023

Enrollment closed • Trial completion date • Diabetic Macular Edema • Ophthalmology

Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P3; N=300; Recruiting; Sponsor: Celltrion; Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology