NEW DELHI: Biocon Biologics introduced that the US Meals and Drug Administration (US FDA) has permitted the corporate’s utility for YESAFILI, the corporate knowledgeable the alternate in a submitting.
“Biocon Biologics’ Obtains US FDA Approval for Biosimilar Aflibercept for Yesafili. Enters US Ophthalmology Market” mentioned the corporate.
After the approval, the corporate entered the ophthalmology therapeutic space in the US.Earlier the corporate additionally acquired approvals in Europe in September and the UK in November final 12 months, the place it was the primary biosimilar aflibercept to be permitted.
“The FDA approval of YESAFILI (aflibercept) as the primary interchangeable organic product to Eylea is a big milestone for Biocon Biologics marking our entry into Ophthalmology, a brand new therapeutic space in the US” mentioned Shreehas Tambe, CEO and MD, Biocon Biologics.
The Firm has additionally secured a launch date in Canada of no later than July 1, 2025, below the phrases of a settlement settlement.
YESDAFILI, a vascular endothelial progress issue (VEGF) inhibitor used to deal with a number of various kinds of ophthalmology circumstances. YESAFILI is meant for the therapy of neovascular age-related macular degeneration, visible impairment as a consequence of macular oedema secondary to retinal vein occlusion (department RVO or central RVO), visible impairment as a consequence of diabetic macular oedema (DME) and visible impairment as a consequence of myopic choroidal neovascularisation (myopic CNV).
“Biosimilars are essential for making healthcare extra reasonably priced and accessible. YESAFILI will supply ophthalmologists an vital new possibility for sufferers impacted by macular degeneration and diabetic retinopathy” mentioned Matt Erick, Chief Business Officer, Biocon Biologics.
There are 19.8 million Individuals dwelling with age-related macular degeneration (AMD) in the US. The gross sales of aflibercept in US have been roughly $5.89 billion in 2023.
“Biocon Biologics’ Obtains US FDA Approval for Biosimilar Aflibercept for Yesafili. Enters US Ophthalmology Market” mentioned the corporate.
After the approval, the corporate entered the ophthalmology therapeutic space in the US.Earlier the corporate additionally acquired approvals in Europe in September and the UK in November final 12 months, the place it was the primary biosimilar aflibercept to be permitted.
“The FDA approval of YESAFILI (aflibercept) as the primary interchangeable organic product to Eylea is a big milestone for Biocon Biologics marking our entry into Ophthalmology, a brand new therapeutic space in the US” mentioned Shreehas Tambe, CEO and MD, Biocon Biologics.
The Firm has additionally secured a launch date in Canada of no later than July 1, 2025, below the phrases of a settlement settlement.
YESDAFILI, a vascular endothelial progress issue (VEGF) inhibitor used to deal with a number of various kinds of ophthalmology circumstances. YESAFILI is meant for the therapy of neovascular age-related macular degeneration, visible impairment as a consequence of macular oedema secondary to retinal vein occlusion (department RVO or central RVO), visible impairment as a consequence of diabetic macular oedema (DME) and visible impairment as a consequence of myopic choroidal neovascularisation (myopic CNV).
“Biosimilars are essential for making healthcare extra reasonably priced and accessible. YESAFILI will supply ophthalmologists an vital new possibility for sufferers impacted by macular degeneration and diabetic retinopathy” mentioned Matt Erick, Chief Business Officer, Biocon Biologics.
There are 19.8 million Individuals dwelling with age-related macular degeneration (AMD) in the US. The gross sales of aflibercept in US have been roughly $5.89 billion in 2023.
