Alteogen has obtained its first biosimilar marketing authorization in Korea.

Biopharmaceutical platform company Alteogen announced through a disclosure on the 15th that it has received marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its Eylea biosimilar “Agenpiju” (development code ALT-L9, generic name aflibercept). The company stated that it has secured all indications held by the originator, including neovascular (wet) age-related macular degeneration, macular edema secondary to retinal vein occlusion, and diabetic macular edema.

This follows its acquisition of marketing authorization in Europe last year (European product name Eyluxvi), and now the company has secured approval in the domestic market as well. ALT-L9 is also the first product to obtain marketing authorization in Korea. As a biosimilar, it is the company’s second product to be approved, following ALT-L2, a Herceptin biosimilar for breast and gastric cancer that received marketing authorization in China.

The latest marketing authorization is based on the results of a global Phase 3 clinical trial conducted by subsidiary Alteogen Biologics in 12 countries, including Korea, Europe, and Japan. In this trial, ALT-L9 demonstrated therapeutic equivalence and safety compared with the originator drug Eylea.

In addition, leveraging its global clinical and regulatory capabilities, Alteogen Biologics is developing ALTS-OP01, a new drug candidate for the treatment of macular degeneration. ALTS-OP01 aims to enhance the efficacy of existing therapies and extend dosing intervals, thereby securing differentiated competitiveness in the ophthalmic disease treatment field. Alteogen is conducting research on formulation technologies and is working to strengthen its foundation for developing follow-on ophthalmic therapies, including filing an international patent (PCT) for high-dose formulation technology.

Jeon Tae-yeon, CEO of Alteogen, said, “Agenpiju is a product that embodies Alteogen’s accumulated capabilities in protein drug development and formulation research,” adding, “It can be seen as a case that demonstrates not only our platform technology, but also Alteogen’s capabilities in drug clinical development and regulatory response.” He further emphasized, “Alteogen will continue to grow into a global biopharma company equipped with both platform technologies and development capabilities.”

Meanwhile, Alteogen recently announced that its U.S. partner MSD obtained a favorable ruling in an ongoing patent litigation with Halozyme regarding formulation platform technology. Analysts say this has helped resolve part of the risks associated with future additional technology out-licensing, including milestone and royalty revenues related to MSD’s Keytruda Qurex. With the favorable outcome in the patent litigation and the visible achievements in drug development such as the latest domestic marketing authorization, Alteogen’s corporate value appears to be returning to an upward trajectory. As of the 15th, Alteogen ranks first on KOSDAQ by market capitalization.

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