Ranibizumab Biosimilar Retains Low Immunogenicity Profile

Ranibizumab biosimilar SB11 (Biogen) appears to have a similarly low immunogenicity profile to ranibizumab (RBZ) itself, according to a poster presented at the American Society of Retina Specialists meeting, held in Seattle, July 28 to August 1, 2023.

Researcher Neil Bressler, MD, an ophthalmology professor at Johns Hopkins University, completed a post hoc analysis of a double-masked, prospective phase III trial regarding the relationship between immunogenicity and clinical efficacy safety outcomes at 1 year of SB11 in neovascular age-related macular degeneration (nAMD). 

Patients (n=705) were randomly assigned to receive either monthly intravitreal 0.5 mg ranibizumab or the ranibizumab biosimilar for up to 48 weeks. The researchers sorted patients by overall and neutralizing antidrug antibodies (ADAs) status to raise statistical power for assessing associations between the products’ outcomes and immunogenicity.

At weeks 0, 1, 4, 8, 24, 36, and 52, patients’ serum ADAs were assessed to determine immunogenicity. Researchers looked for intraocular inflammation-related adverse events to assess safety and best corrected visual acuity (BCVA) and central subfield thickness (CST), based ADA status, to determine efficacy. ADA status reflected the count of ADA-positive results. 

ADA positive response was low and did not vary by treatment. At 1 year, immunogenicity was [ranibizumab biosimilar: 14 (4.2%), ranibizumab: 18 (5.5%)] and change from baseline in BCVA (ADA positive =11.7 [2.16] letters and ADA negative=10.1 [0.61] letters; difference, 1.6 letters [95% CI: -2.7, 5.8]; P =.46) and CST (ADA positive=-130.2 [13.0] µm and ADA negative=-133.0 [3.7] µm; difference, 2.9 µm [95% CI: -22.8, 28.5]; P =.83) were not linked with ADA status. Intraocular inflammation was infrequent. No new safety concerns presented regarding immunogenicity of the ranibizumab biosimilar.

“The immunogenicity profile was low and did not appear different comparing SB11 with RBZ,” Dr Bressler explained. “Immunogenicity in this trial did not seem to be associated with efficacy or safety outcomes of RBZ products, supporting its safe and effective use in clinical practice.”

Limitations of the study included that solely 3 participants among the pharmacokinetics (PK) population of 44 developed ADA. Immunogenicity and PK of the 2 treatments remains possible since mean serum RBZ concentrations had fewer ADA-positive participants compared with ADA-negative ones.

Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.