Ophthalmic biosimilars and biologics—role of endotoxins

Sharma, Ashish; Kumar, Nilesh; Kuppermann, Baruch D.; Bandello, Francesco; Loewenstein, Anat

doi:10.1038/s41433-019-0636-3

Cited by 11 publications

(13 citation statements)

References 12 publications

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“…Ten percent of patients who received injections from the first three batches Razumab experienced post-injection inflammation [ 42 ]. An additional filtration step was then added to the manufacturing process, and endotoxin limits were corrected [ 43 , 44 ]. After these modifications, the rate of ocular inflammation was significantly reduced [ 45 ].…”

Section: Sterile Intraocular Inflammationmentioning

confidence: 99%

Inflammatory Complications of Intravitreal Anti-VEGF Injections

Cox

Eliott

Sobrin

2021

JCM

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Intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents is a commonly used therapy for numerous retinal diseases. The most commonly used of these medications are bevacizumab, ranibizumab, aflibercept, and brolucizumab. However, intravitreal administration of these agents is also associated with several inflammatory and non-inflammatory adverse events. The three inflammatory adverse events are sterile intraocular inflammation, brolucizumab-associated retinal vasculitis, and post-injection endophthalmitis. This narrative review summarizes the current literature regarding these conditions, including their epidemiology, presentation, management, outcomes, and pathogenesis. The inflammatory adverse events also share a number of overlapping features, which can make them difficult to discern from one another in a clinical context. This review discusses certain distinguishing features of these conditions that may aid providers in discerning between them and establishing the correct diagnosis.

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Section: Sterile Intraocular Inflammationmentioning

confidence: 99%

Inflammatory Complications of Intravitreal Anti-VEGF Injections

Cox

Eliott

Sobrin

2021

JCM

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“…Intas introduced an additional filtration step to its manufacturing process and added fresh “ultrapure Polysorbate 20”. [ 10 ] Furthermore, endotoxin limits were also re-defined and corrected [ 11 ]. After addressing these manufacturing issues, no cases of inflammation have been reported further with the drug.…”

mentioning

confidence: 99%

Brolucizumab and immunogenicity

Sharma¹,

Kumar²,

Parachuri³

et al. 2020

Eye

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“…The reason attributing to the ADR was found to be due to an increase in the levels of bacterial endotoxin. 29 The major difference between generic drugs and its biosimilar is that, generic drugs are manufactured based on matching the chemical formula and synthesis, whereas the manufacturing of biosimilars such as Razumab will not have access to manufacturing process of innovator products, as this is a proprietary knowledge. [29][30][31][32][33] Razumab manufacturing involves living cells (Escherichia coli expression system) in the process and even a slight change from the originator molecules for example protein folding can readily modify its safety and efficacy.…”

Section: Discussionmentioning

confidence: 99%

“…[34][35][36] Extrinsic endotoxins can be attributed to improper sterilization and storage, whereas intrinsic endotoxins originate during inherent drug manufacturing process. 29 A presentation from the market research 2017 in the vireo-retinal society of India website 37 demonstrated there are significant variations in the cost of treatment between Ranibizumab and its biosimilar. Quoting from a newspaper article, published in December 2017, the data from the 60th round of the National Sample Survey, conducted in 2004, had shown that 70% of out-of-pocket expenditure is on medicines.…”

Section: Discussionmentioning

confidence: 99%

A comparative study between ranibizumab and its first biosimilar razumab in terms of efficacy and safety in DME, RVO and wet AMD associated with CNVM

Preethi¹,

Shilpa²,

Shah³

et al. 2021

IJCEO

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To compare safety and efficacy of intravitreal therapy between anti vascular endothelial growth factor (Anti-VEGF) Ranibizumab and biosimilar Razumab in diabetic macular oedema (DME), wet age related macular degeneration (AMD) with choroidal neovascular membrane (CNVM) and retinal vein occlusion (RVO). Prospective comparative study involved 60 eyes of 56 adults, randomized into 2 groups from September 2016 to November 2017. Group 1 (n=30) received Ranibizumab (0.5mg in 0.05ml) and group 2(n=30) Razumab (0.5mg in 0.05ml). Initial loading dose of one injection given to all subjects and a pro re nata schedule followed thereafter. Patients received maximum of 3 injections and were followed up to 12 weeks. Best corrected visual acuity (BCVA) and central foveal thickness (CFT) were considered for the primary outcome and adverse drug reactions (ADR) was considered in the secondary outcome. A p value of less than 0.05 was considered statistically significant. The 12-week mean BCVA in group 1 was 0.39 (+-0.24); and in group 2 was 0.53 (+-0.37), which had improved significantly from baseline (group 1 p= 0.007, group 2 p <0.001). Inter group comparison was statistically insignificant (p=0.249). The 12 weeks mean CFT in group 1 was 308 (+-107.26) ; and group 2 was 307.60 (+- 87.15), which had improved significantly from baseline in both groups (p <0.001). Inter group difference was statistically insignificant (p=0.544). One patient in group 2 experienced an ADR (p=0.305). In this study both Ranibizumab and Razumab were safe and efficacious.

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Ophthalmic biosimilars and biologics—role of endotoxins

Cited by 11 publications

References 12 publications

Inflammatory Complications of Intravitreal Anti-VEGF Injections

Inflammatory Complications of Intravitreal Anti-VEGF Injections

Brolucizumab and immunogenicity

A comparative study between ranibizumab and its first biosimilar razumab in terms of efficacy and safety in DME, RVO and wet AMD associated with CNVM

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