The Development Pathway for Biosimilar Biotherapeutics

Zarbin, Marco A.

doi:10.18502/jovr.v15i3.7444

Cited by 1 publication

(1 citation statement)

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“…Therefore, biosimilars are the end products similar to the original molecule with minor non-significant differences. [9][10][11][12] In February 2015, Razumab® (Intas Pharmaceuticals, Ahmedabad, India), the first biosimilar to ranibizumab, was approved by the drug controller general of India for the treatment of nAMD, DME, RVO-associated macular edema, and myopic choroidal neovascularization. In a prospective study, the safety and efficacy of Razumab® was demonstrated in Indian patients with retinal vascular diseases including RVO.…”

Section: Discussionmentioning

confidence: 99%

Intraocular Injection of Stivant® (A Biosimilar to Bevacizumab): A Case Series

Mirshahi

Lashay

Riazi-Esfahani

et al. 2021

JOVR

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Purpose: To report the results of intravitreal injection of a bevacizumab biosimilar called Stivant®. Methods: This prospective interventional case series was conducted on eyes with neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME). Stivant® was injected in three consecutive months and changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at baseline and monthly up to one month after the third injection. Results: Three hundred and eighty-five eyes with DME (234 eyes, 61%), nAMD (87 eyes, 22%), and macular edema secondary to RVO (64 eyes, 17%) were enrolled. The mean ± standard deviation age of the patients was 61.7 ± 7.20 years. The mean BCVA and CMT changed from 0.63 ± 0.3 to 0.51 ± 0.3 LogMAR (P = 0.12 ) and from 420.4 ± 47.3μm at baseline to 316.7 ± 50.6 μm (P < 0.001) in the DME group; from 0.79 ± 0.3 to 0.68 ± 0.3 LogMAR (P = 0.19) and from 376.1 ± 31.7 μm to 303 ± 31.3 μm (P = 0.019) in the nAMD group; and from 0.81 ± 0.4 to 0.63 ± 0.4 LogMAR (P = 0.05) and from 424.21 ± 18 μm to 303.4 ± 18.8 μm (P < 0.001) in the RVO group, respectively. Conclusion: Our limited experience showed that the intravitreal injection of Stivant® was well tolerated. Although the results of this case series showed relative improvement in CMT one month after the last injection of Stivant®, BCVA improvement was statistically significant only in the RVO group. This would be essential to design a randomized clinical trial to evaluate the non-inferiority of Stivant® in comparison to bevacizumab.

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Section: Discussionmentioning

confidence: 99%