[Hinews] Celltrion, a South Korean biopharmaceutical company, announced on October 10, 2025, that its biosimilar drug Idenzent (CT-P42), a counterpart to the blockbuster eye treatment Eylea (aflibercept), has received approval from the U.S. Food and Drug Administration (FDA). The approval marks a significant milestone for Celltrion, enabling the company to enter the world’s largest pharmaceutical market with a drug already authorized in South Korea, Europe, and Australia.

The FDA greenlit Idenzent in two formulations: vials and pre-filled syringes (PFS). The biosimilar is approved for the full range of Eylea’s indications, including neovascular (wet) age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and retinal vein occlusion (RVO). The approval was supported by data from a global Phase 3 clinical trial involving 348 patients with DME, which demonstrated Idenzent’s therapeutic equivalence to Eylea. Additionally, 52-week clinical data published in a global academic journal further validated the drug’s efficacy and safety.

Celltrion CI (Photo provided by Celltrion)
Celltrion CI (Photo provided by Celltrion)


Eylea, a leading ophthalmic therapy, generates approximately $11 billion in annual global sales, with roughly $7 billion stemming from the U.S. market. Celltrion’s entry into this lucrative segment strengthens its portfolio of 11 biosimilar drugs currently available in the U.S. The company aims to register five additional products in 2025, signaling an aggressive push to expand its footprint in the American biopharmaceutical market.

A Celltrion spokesperson stated, “With FDA approval, we plan to solidify our position in the ophthalmic treatment market. Our focus will be on ensuring stable supply and consistent quality as we move forward with commercialization.”
This development underscores South Korea’s growing influence in the global biosimilar industry, where companies like Celltrion leverage advanced biotechnology to offer cost-effective alternatives to high-priced biologics. For U.S. patients and healthcare providers, Idenzent’s approval introduces a new option for managing debilitating eye conditions, potentially improving access to critical treatments.

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