Korea-based global pharmaceutical company Celltrion has announced approval from the Therapeutic Goods Administration (TGA) of Australia of its ophthalmic treatment ‘Eydenzelt’ (ingredient name: Aflibercept).
‘Eydenzelt’ is a biosimilar of Regeneron/Bayer’s Eylea and is approved for the treatment of myopic choroidal neovascularisation.
As reported in a number of outlets, the approved formulations include injectable and prefilled syringe versions.
It is the first Aflibercept biosimilar approved in Australia, and the company expects to gain a competitive edge in the market.
The original drug, Eylea, recorded global sales of $9.523 billion (13.33 trillion won) last year.
The original products of ‘Stoboclo’ and ‘Osenvelt’, Prolia and Xgeva, had combined global sales of approximately $6.599 billion (9.2 trillion won) last year.
Celltrion expects that the approval of this biosimilar and two others not for use in ophthalmics will significantly enhance its competitiveness in the Oceania market.
In the news reports, a Celltrion official said: “With the consecutive approvals, the company’s competitiveness and influence in the biosimilar-friendly Oceania market are expected to be further strengthened.
“We will do our best to promptly complete the remaining commercialisation procedures and ensure that the products can be smoothly supplied in the market.”
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