Celltrion Ophthalmic Biosimilar 'IdenzelT' Approved Domestically

Celltrion announced on the 30th that its biosimilar of the ophthalmic disease treatment drug Eylea, Idelzent (development name CT-P42), has received marketing authorization approval from the Ministry of Food and Drug Safety.

Incheon Songdo Celltrion Plant 2 exterior view. / Incheon Photo by Hyunmin Kim kimhyun81@

Eylea is an ophthalmic disease treatment drug for macular degeneration jointly developed by Regeneron in the United States and Bayer in Germany. Macular degeneration is considered a representative cause of blindness. Blood and other fluids leaking from abnormally grown capillaries in the macula, the core of the retina, adhere to the retina and block vision. Aging is a major cause, so the incidence is rapidly increasing amid the global aging trend. Global market research firm GlobalData forecasts that the macular degeneration treatment market in the seven major G7 countries, including the United States, France, and Germany, will grow from $7.4 billion in 2021 to $27.5 billion (approximately 37.7163 trillion KRW) by 2031.

Macular degeneration is treated by regularly injecting drugs such as Eylea, which inhibits new blood vessel formation, or Lucentis, an antibody treatment with a similar mechanism, directly into the eye to suppress disease progression. Eylea recorded sales of $9.36 billion (approximately 12.8372 trillion KRW) last year, and although Lucentis’s sales have sharply declined due to the launch of biosimilars, it still records annual sales of $1.475 billion (approximately 2 trillion KRW). The domestic market size for Eylea is also estimated to be about 94 billion KRW.

The approval of Idelzent is significant as Celltrion’s first ophthalmic disease biosimilar. The company has expanded its portfolio from autoimmune diseases and anticancer drugs to include ophthalmic diseases. Based on global Phase 3 clinical trial results, Celltrion applied for marketing authorization for Idelzent in July last year and obtained approval for all indications that Eylea holds domestically, including wet macular degeneration and diabetic macular edema. The formulations include two types: a general injection and a prefilled syringe (PFS).

Previously, Celltrion confirmed the equivalence and similarity of Idelzent to the original drug through a global Phase 3 clinical trial involving 348 patients with diabetic macular edema in 13 countries, including Spain and Poland. Based on this, approval procedures are underway in major global countries such as the United States, Europe, and Canada, in addition to Korea.

A Celltrion official said, “With the marketing authorization of Idelzent, we can actively target the rapidly growing ophthalmic disease treatment market, including macular degeneration and macular edema. Domestically, Celltrion Pharm, which secured the distribution rights, has already completed preliminary preparations for distribution with partners who have an ophthalmic disease sales network and has entered the full-scale market entry process. We will do our best to supply high-quality biopharmaceuticals quickly to more patients.”