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FDA approves 2 Eylea biosimilars

Yesafili and Opuviz are interchangeable biosimilars to Regeneron's Eylea.

The Food and Drug Administration has approved Biocon Biologics' Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen's Opuviz (aflibercept-yszy) as interchangeable biosimilars to Regeneron's Eylea (aflibercept). 

Aflibercept products work by inhibiting vascular endothelial growth factor, which prevents abnormal blood vessel growth within the eye. By blocking VEGF, aflibercept products can slow down or reduce damage to the retina and help preserve vision.

[Read more: Prioritizing Lower-Priced Biosimilar Medications]

Both Yesafili and Opuviz are used to treat:

  • Neovascular (wet) age-related macular degeneration
  • Macular edema following retinal vein occlusion
  • Diabetic macular edema; and
  • Diabetic retinopathy.

Both Yesafili and Opuviz are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/ml) injectable solution to treat patients for the conditions listed above according to dosing regimens as recommended in the labeling, per the FDA.

[Read more: AAM report: Generic, biosimilar drugs generate $408B in savings]

Shreehas Tambe, CEO and managing director of 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 (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."  

"Biosimilars are crucial for making health care more affordable and accessible," said Matt Erick, chief commercial officer of advanced markets at Biocon Biologics. "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."

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