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Samsung Bioepis & Biocon Receive First US Approvals of Aflibercept Biosimilars with Interchangeability

May 20, 2024

On 20 May 2024, Samsung Bioepis and Biocon won the race to be the first FDA approved interchangeable biosimilars to Regeneron’s Eylea®(aflibercept). Both Samsung Bioepis’ Opuviz (aflibercept-yszy) and Biocon’s YesafiliTM (aflibercept-jbvf) are approved for nAMD, macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular oedema.

The US launch dates for the products remain uncertain due to ongoing patent litigation brought by Regeneron against Samsung Bioepis and Biocon (amongst others) regarding aflibercept.  As previously reported, on 17 May 2024, a temporary (14 day) restraining order was granted against Biocon, preventing it from manufacturing, using, marketing and selling its Yesafili® (aflibercept) biosimilar in, or importing it into, the US without a licence from Regeneron.

In March 2024, Biocon announced a settlement with Regeneron and Bayer under which it can launch Yesafili in Canada from 1 July 2025.  Biocon has also received marketing approval for Yesafili in the UK (November 2023) and the EU (September 2023).

Samsung Bioepis’ Afilivu® (SB15, aflibercept) received Korean approval in February 2024.  In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024.