Biocon Biologics Gets USFDA Approval for Biosimilar Ophthalmology Drug
By Rediff Money Desk, New Delhi May 21, 2024 11:06
Biocon Biologics has received USFDA approval for Yesafili, a biosimilar to Eylea (aflibercept), for treating various ophthalmology conditions like age-related macular degeneration.

Photograph: Kind courtesy Biocon Biologics/Facebook
New Delhi, May 21 (PTI) Biocon Biologics on Tuesday said it has received approval from the US health regulator for its biosimilar product to treat different types of ophthalmology conditions.
The US Food and Drug Administration (USFDA) has approved the company's first-to-file application for Yesafili, a vascular endothelial growth factor inhibitor used to treat several different types of ophthalmology conditions, the company said in a statement.
Biocon Biologics is a part of Biocon Ltd.
Yesafili is intended for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation.
It is similar to the reference product Eylea (aflibercept).
"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 US," Biocon Biologics CEO & Managing Director Shreehas Tambe said.
As per the company, there are 19.8 million Americans living with age-related macular degeneration in the US. In the US, sales of aflibercept stood at around USD 5.89 billion in 2023.
The US Food and Drug Administration (USFDA) has approved the company's first-to-file application for Yesafili, a vascular endothelial growth factor inhibitor used to treat several different types of ophthalmology conditions, the company said in a statement.
Biocon Biologics is a part of Biocon Ltd.
Yesafili is intended for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation.
It is similar to the reference product Eylea (aflibercept).
"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 US," Biocon Biologics CEO & Managing Director Shreehas Tambe said.
As per the company, there are 19.8 million Americans living with age-related macular degeneration in the US. In the US, sales of aflibercept stood at around USD 5.89 billion in 2023.
Source: PTI
Read More On:
DISCLAIMER - This article is from a syndicated feed. The original source is responsible for accuracy, views & content ownership. Views expressed may not reflect those of rediff.com India Limited.
You May Like To Read
TODAY'S MOST TRADED COMPANIES
- Company Name
- Price
- Volume
- Vodafone Idea L
- 9.12 ( -3.70)
- 28487876
- Srestha Finvest
- 0.65 ( -5.80)
- 17244407
- Murae Organisor
- 1.85 (+ 4.52)
- 16017942
- Quadrant Televenture
- 0.52 (+ 4.00)
- 15423224
- Sunshine Capital
- 0.86 ( -4.44)
- 12894409
MORE NEWS

India Steel Industry Worried Over US Tariffs
The Indian Steel Association expresses deep concern over the US decision to impose...

Bata India Q3 Profit Up 1.2% to Rs 59 cr -...
Bata India reported a 1.2% rise in Q3 net profit to Rs 58.7 crore, driven by volume-led...

RBI Doubles OMO Purchase to Rs 40,000 Cr
The Reserve Bank of India has increased the amount of open market operations (OMO)...