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22 May 2024
Admin
News Article

Biocon Biologics Gets US FDA Nod for Biosimilar Aflibercept to Treat Different Types of Ophthalmology Conditions

Biocon Biologics gets US FDA nod for biosimilar aflibercept to treat different types of ophthalmology conditions

Overview

Biocon Biologics announced that the US FDA has approved the company’s first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product Eylea (aflibercept).

Yesafili Use

Yesafili is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
It is highly similar to the reference product Eylea. Data shows that Yesafili has comparable quality, safety, and efficacy to Eylea.

Biocon Biologics’ Expansion

The approval of Yesafili marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States following a steady track record of approval in Europe in September 2023 and the UK in November 2023 where it was the first biosimilar aflibercept to be approved.
The company has secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement.

Words from CEO: Biocon Biologics

Shreehas Tambe, CEO & managing director, Biocon Biologics said: ""The FDA approval of Yesafili (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into ophthalmology, a new therapeutic area in the United States. Yesafili is approved for the treatment of neovascular or wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. This approval builds on our successful track record of bringing the first interchangeable insulin, Semglee, the first biosimilar Trastuzumab, Ogivri, and the first biosimilar Pegfilgrastim, Fulphila, to patients in the United States."

From CCO: Biocon Biologics

Matt Erick, chief commercial officer of advanced markets, Biocon Biologics said: “Biosimilars are crucial for making healthcare more affordable and accessible. Yesafili will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy, from a company with a long history of delivering high-quality, science-driven medicines, solely focused on the development and commercialization of biosimilars."

Aflibercept: Sale

There are 19.8 million Americans living with age-related macular degeneration (AMD) in the United States. In the US, sales of aflibercept were approximately $5.89 billion in 2023.

Biocon Biologics

Biocon Biologics has achieved several ‘firsts’ in the industry including the first to receive approval in the US for a biosimilar trastuzumab (Ogivri, trastuzumab-dkst) and a biosimilar pegfilgrastim (Fulphila, pegfilgrastim-jmdb).

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