Approval in Canada follows domestic, European, Australian, and US markets Expanding treatment areas for autoimmune, bone, and eye diseases Increased competitiveness in North American market… Portfolio expansion progressing smoothly
Celltrion Eydenzelt Product Image
Celltrion announced on the 28th that its biosimilar product for the ophthalmic disease treatment Eylea (active ingredient: aflibercept), named 'Eydenzelt (development name CT-P42)', has received marketing authorization from Health Canada.
Eydenzelt has secured indications held by the original drug for adults, including neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV). The approved formulations include two types: Vial and Pre-filled Syringe (PFS).
Celltrion is accelerating its efforts to penetrate the global ophthalmic disease treatment market by obtaining Eydenzelt approvals in major countries, including South Korea, Europe, Australia, the United States, and Canada. Particularly, with the Canadian approval following the United States, Celltrion has strengthened its position in North America, the world's largest pharmaceutical market.
Canada is one of the countries actively promoting biosimilar-friendly policies, recently indicating the possibility of regulatory relaxation and other institutional improvements, aligning with the global pro-biosimilar trend. In Canada, Celltrion has established a diverse product portfolio across treatment areas such as autoimmune diseases, oncology, allergies, and bone diseases. The approval of this ophthalmic disease treatment allows for further expansion of treatment areas.
The original drug Eylea, Eydenzelt's reference product, recorded global sales of USD 9.523 billion (approximately KRW 13.3322 trillion) last year, making it a blockbuster ophthalmic disease treatment.
A Celltrion representative stated, “We are continuously enhancing our competitiveness in the North American market through successive portfolio expansions,” and added, “With the Canadian approval securing Eydenzelt authorization in both major North American markets, we will swiftly complete the remaining commercialization processes to actively drive sales expansion.”
Kim Min-beom
AI-translated with ChatGPT. Provided as is; original Korean text prevails.
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