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FDA approves Samsung and Biocon¡¯s Eylea biosimilars

By Son, Hyung-Min | translator Kang, Shin-Kook

24.05.22 05:55:39

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Samsung Bioepis¡¯s Opuviz and Biocon Biologics's Yesafili receives approval in the US

Both products were approved with interchangeability designations¡¦can be substituted for the reference product at the pharmacy level without doctors¡¯ prescriptions

Competition in the AMD market intensifies with the introduction of Eylea biosimilars and Vabysmo


Samsung Bioepis¡¯s Opuviz became the first Eylea biosimilar to be approved in the US. In particular, due to its interchangeability designation, Opuviz can be administered interchangeably with Eylea, increasing its chances of gaining an advantage in the market over its competitors.

According to KoreaBIO on the 21st, the US FDA approved Samsung Bioepis¡¯s Opuviz and the Indian Biocon Biologics's Yesafili as interchangeable biosimilars that can substitute the original macular degeneration treatment Eylea. The approval will allow pharmacies in the US to make substitutions of Eylea at the pharmacy level without an additional physician¡¯s prescription.

The FDA began designating interchangeable

Son, Hyung-Min(shm@dailypharm.com)
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