OBJECTIVE: This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD). DESIGN: This was a multicenter, double-masked, randomized, controlled phase III trial. PARTICIPANTS: Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab. METHODS: Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks. MAIN OUTCOME MEASURES: The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between -3.49 and +3.49. RESULTS: Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, -2.23 to 0.13) and 95% CI (-2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups. CONCLUSIONS: QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Clinical Research and Development Centre Qilu Pharmaceutical Jinan China

Department of Ophthalmology Bajcsy Zsilinszky Hospital Budapest Hungary

Department of Ophthalmology Barraquer Ophthalmology Center Barcelona Spain

Department of Ophthalmology Beijing Tongren Eye Center Beijing Tongren Hospital Capital Medical University Beijing China

Department of Ophthalmology Clinical Centre Bikernieki Riga East University Hospital Riga Latvia

Department of Ophthalmology Comenius University University Hospital Ružinov Ružinovská Bratislava Slovakia

Department of Ophthalmology Diagnostic and Microsurgery Center of the Eye LENS Olsztyn Poland

Department of Ophthalmology MJ Western Regional Institute of Ophthalmology Ahmedabad Gujarat India

Department of Ophthalmology Pauls Stradins Clinical University Hospital Riga Latvia

Department of Ophthalmology Regional Institute of Ophthalmology Medical College Kolkata West Bengal India

Department of Ophthalmology Retina Ophthalmological Outpatient Clinic and Hospital Warsaw Poland

Department of Ophthalmology Semmelweis University Budapest Hungary

Department of Ophthalmology Shivam Retina Clinic and Eye Hospital Vadodara Gujarat India

Department of Ophthalmology St Rose Hospital Kraków Poland

Department of Ophthalmology Tianjin Eye Hospital Tianjin China

Department of Ophthalmology University Hospital and Policlinic of Zilina Zilina Slovakia

Department of Ophthalmology University Hospital Kralovske Vinohrady Prague Czech Republic

Department of Ophthalmology University of Debrecen Debrecen Hungary

Department of Vitreoretinal Surgery Medical University of Lublin Independent Public Teaching Hospital No 1 Lublin Poland

Ophthalmology and Eye Surgery Clinic Warsaw Eye Hospital Warsaw Poland

Retina and Vitreous Department Institut Català de Retina Barcelona Spain

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