Biosimilars for Retinal Diseases: An Update

Ranizurel safety evaluation in real-world -(RaSER) study

“…Biosimilars in essence are similar to the innovator biologic or reference product with similar efficacy and safety profile and provide a cost-benefit of 20–30% compared to the reference molecules. 2 The perception of biosimilars being generic drugs with poor safety and efficacy though has produced a nocebo effect. This has been scientifically disproved by the high safety profile of Razumab (Intas Pharmaceutical Ltd, Ahmedabad, India), the world's first biosimilar for ophthalmic use.…”

Deliver protein across bio-barriers via hexa-histidine metal assemblies for therapy: a case in corneal neovascularization model

“…Avastin (Ava) with a molecular weight (Mw) of 149 ​kDa, composed of two 214-residue light chains and two 453-residue heavy chains, was engineered to target VEGF-A (vascular endothelial growth factor A) and block angiogenesis [ 20 , 21 ]. Ava ​has been widely applied in treating neovascularization-related diseases, including cancer and age-related macular degeneration, since it has been approved by the United States Food and Drug Administration in 2004 for clinical use [ 22 , 23 ]. Recently, Ava and its analogous antibodies have been widely used in ophthalmology because of their safety and effectiveness in inhibiting fundus neovascular diseases (diabetic retinopathy, exudative age-related macular disease, neovascular glaucoma) in the clinic [ 24 ], which has attracted extensive interest in treating CNV [ 25 ].…”

Biosimilars for Retinal Diseases: Understanding the Phase 3 Clinical Trial Design

“…There has been a growing interest in the biosimilars of anti-vascular endothelial growth factors (anti-VEGF). (1) There are various biosimilar molecules of ranibizumab and aflibercept at various stages of clinical trials. (1) Results of the Phase 3 trials of two molecules FYB 201 and SB11 (biosimilars of ranibizumab) have been published recently.…”

“…(1) There are various biosimilar molecules of ranibizumab and aflibercept at various stages of clinical trials. (1) Results of the Phase 3 trials of two molecules FYB 201 and SB11 (biosimilars of ranibizumab) have been published recently. The study design and regulatory pathway for biosimilars have unique features compared to originator molecules.…”

“…(2,3) Most of the biosimilars of ranibizumab that have completed or are undergoing phase 3 clinical trials have primary endpoint analysis (visual acuity and macular thickness) at 4 or 8 weeks, though a variety of secondary efficacy end point data (including BCVA) is collected through the length of the trials, which are typically up to 12 months long. (1) In contrast, reference originator molecules usually have primary efficacy endpoints at 12 months. This early primary efficacy endpoint in biosimilar trials is a new concept for the retina specialists who are used to extensive long term data end points since the introduction of anti-VEGFs in this field.…”