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FDA Approves Biocon Biologics’ Yesafili, an Eylea Biosimilar, for the Treatment of Multiple Ophthalmic Conditions

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Approval of Yesafili represents Biocon’s entrance into the US ophthalmology market, following previous approvals in Europe and the UK.

Security access technology/Eye viewing digital information represented by circles and signs, background depth of field. Technology concept. Image Credit: Adobe Stock Images/spainter_vfx

Image Credit: Adobe Stock Images/spainter_vfx

Biocon Biologics announced that it has received FDA approval for Yesafili (aflibercept-jbvf), a biosimilar to Eylea (aflibercept). According to the company, Yesafili is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of several ophthalmic conditions such as neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). Prior to being approved by the FDA, Yesafili was cleared in the United Kingdom back in November, while European approval came in September. Additionally, it is expected to launch in Canada by July 1, 2025.1

"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 (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,” said Shreehas Tambe, CEO, Managing Director, Biocon Biologics, in a press release.

As alluded to above, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) also offered a positive opinion for Yesafili back in July, while approval came shortly after. Reportedly, data that lead to the positive opinion showed that Yesafili demonstrated comparable quality, safety, and efficacy to Eylea.1,2

"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,” said Matt Erick, chief commercial officer, Advanced Markets, Biocon Biologics, in a press release.

According to the World Health Organization (WHO), at least 2.2 billion people have a form of vision impairment. Close to half of those cases could have been avoided or have yet to be tackled. WHO suggests that the leading cause of blindness or other vision issues are a result of refractive errors and cataracts. Further, only 36% of individuals with a distance vision impairment due to refractive error and only 17% of people with vision impairment due to cataract have been provided with the proper treatment.3

“Vision impairment has serious consequences for the individual across the life course. Many of these consequences can be mitigated by timely access to quality eye care,” reports WHO. “Eye conditions that can cause vision impairment and blindness – such as cataract or refractive error – are, for good reasons, the main focus of eye care strategies; nevertheless, the importance of eye conditions that do not typically cause vision impairment – such as dry eye or conjunctivitis – must not be overlooked. These conditions are frequently among the leading reasons for presentation to eye care services.”

References

1. Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili™. Enters U.S. Ophthalmology Market. PR Newswire. May 21, 2024. Accessed May 21, 2024. https://www.prnewswire.com/news-releases/biocon-biologics-obtains-us-fda-approval-for-biosimilar-aflibercept-for-yesafili-enters-us-ophthalmology-market-302150830.html

2. Biocon Biologics Announces Positive CHMP Opinion for YESAFILI®, Biosimilar Aflibercept. PR Newswire. July 24, 2023. Accessed May 21, 2024. https://www.prnewswire.com/news-releases/biocon-biologics-announces-positive-chmp-opinion-for-yesafili-biosimilar-aflibercept-301883594.html

3. Blindness and vision impairment. WHO. August 10, 2023. Accessed May 21, 2024. https://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment

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