Alteogen has received domestic approval for its Eylea biosimilar, Izenpiju, marking its entry into a market estimated at approximately 13 trillion won ($10 billion). This development is expected to intensify competition among domestic companies, including Samsung Bioepis, Celltrion, and Samchundang Pharm, who have already entered the market.
According to industry sources on May 17, Alteogen recently obtained approval from the Ministry of Food and Drug Safety for Izenpiju. This approval follows last year's authorization in Europe, signifying a significant step for Alteogen in translating its research and development capabilities into the commercialization of biosimilars.
Eylea is a blockbuster treatment for major eye diseases, including age-related macular degeneration, and is considered a cash cow due to stable and ongoing demand driven by aging populations and long-term treatment needs.
Samsung Bioepis was the first to act in the domestic market, securing approval for its Eylea biosimilar, Apilibu, and establishing a co-marketing system with Samil Pharmaceutical. Celltrion has also entered the market with its product, Idenselt, collaborating with International Pharmaceutical to expand its ophthalmic sales network. With the addition of Samchundang Pharm's Vigenpri, the Eylea biosimilar market has transitioned from mere approval competition to a full-scale commercialization battle over sales networks and prescription channels.
However, industry experts caution that the high sales figures of the original Eylea may not directly translate into profitability for biosimilar companies. Biosimilars typically expand their market share based on lower prices compared to the original, making the timing of launch, reimbursement listings, and securing prescription networks critical factors for success. New entrants without differentiation may face intense price competition, and delays in capturing initial market share could quickly diminish expected profit margins.
Despite these challenges, the ophthalmic disease sector is viewed as a key battleground for biosimilar companies due to steady market formation driven by aging populations and long-term treatment needs. Ophthalmic indications have a broad patient base and long treatment durations, providing revenue stability through repeat prescriptions once established in the market.
While Alteogen has been recognized as a platform technology company, this approval demonstrates its capability in commercializing its own developed biosimilars. The company plans to leverage this approval to push for domestic launch while simultaneously developing follow-up candidates for new age-related macular degeneration treatments. Industry analysts interpret Alteogen's entry not merely as an addition of a product but as a strategic shift to broaden its portfolio from a technology platform-focused business to include the ophthalmic disease sector.
A pharmaceutical industry official stated, "The competition in ophthalmic diseases is expected to heat up further. The key will be who can establish themselves in the market more quickly, with securing sales networks and reimbursement strategies being crucial factors for future success."
According to industry sources on May 17, Alteogen recently obtained approval from the Ministry of Food and Drug Safety for Izenpiju. This approval follows last year's authorization in Europe, signifying a significant step for Alteogen in translating its research and development capabilities into the commercialization of biosimilars.
Eylea is a blockbuster treatment for major eye diseases, including age-related macular degeneration, and is considered a cash cow due to stable and ongoing demand driven by aging populations and long-term treatment needs.
Samsung Bioepis was the first to act in the domestic market, securing approval for its Eylea biosimilar, Apilibu, and establishing a co-marketing system with Samil Pharmaceutical. Celltrion has also entered the market with its product, Idenselt, collaborating with International Pharmaceutical to expand its ophthalmic sales network. With the addition of Samchundang Pharm's Vigenpri, the Eylea biosimilar market has transitioned from mere approval competition to a full-scale commercialization battle over sales networks and prescription channels.
However, industry experts caution that the high sales figures of the original Eylea may not directly translate into profitability for biosimilar companies. Biosimilars typically expand their market share based on lower prices compared to the original, making the timing of launch, reimbursement listings, and securing prescription networks critical factors for success. New entrants without differentiation may face intense price competition, and delays in capturing initial market share could quickly diminish expected profit margins.
Despite these challenges, the ophthalmic disease sector is viewed as a key battleground for biosimilar companies due to steady market formation driven by aging populations and long-term treatment needs. Ophthalmic indications have a broad patient base and long treatment durations, providing revenue stability through repeat prescriptions once established in the market.
While Alteogen has been recognized as a platform technology company, this approval demonstrates its capability in commercializing its own developed biosimilars. The company plans to leverage this approval to push for domestic launch while simultaneously developing follow-up candidates for new age-related macular degeneration treatments. Industry analysts interpret Alteogen's entry not merely as an addition of a product but as a strategic shift to broaden its portfolio from a technology platform-focused business to include the ophthalmic disease sector.
A pharmaceutical industry official stated, "The competition in ophthalmic diseases is expected to heat up further. The key will be who can establish themselves in the market more quickly, with securing sales networks and reimbursement strategies being crucial factors for future success."
* This article has been translated by AI.
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