Alteogen is accelerating its push to build an "ophthalmology platform" for new drug development and global business expansion, going beyond simple biosimilar sales, following domestic approval of its Eylea biosimilar. The company plans to differentiate itself through a specialized ophthalmology sales network and a global licensing-out (LO) strategy.
According to industry sources on the 15th, Alteogen recently obtained product approval from the Ministry of Food and Drug Safety for its Eylea biosimilar "Eyzenfi Injection (ALT-L9)." Eylea is a global blockbuster ophthalmic treatment used for macular degeneration and diabetic retinopathy, with the global market estimated at approximately 13 trillion won.
In the domestic market, competing products from Samsung Bioepis and Celltrion have already been launched. To overcome its disadvantage as a late entrant, Alteogen selected Hanlim Pharm, a company with strengths in ophthalmology sales, as its domestic sales partner. "Ultimately, marketing and sales capabilities are what matter in the market," an Alteogen official said. "We determined that Hanlim Pharm is specialized in the ophthalmology field and decided to work with them starting at the clinical stage."
In overseas markets, Alteogen is also pursuing a strategy centered on local partners rather than direct sales. After obtaining product approval for "Eyluxvi," its Eylea biosimilar in Europe, the company has signed licensing-out agreements with local ophthalmology specialists primarily in regions such as the Middle East and South America.
The decision reflects the view that, given that major pharmaceutical companies such as Sandoz are also competing for sales in the global ophthalmic treatment market, leveraging partners with strong understanding of local markets is more efficient than building an in-house sales organization from the outset.
The company is also preparing to enter the US market, but patent risk remains a variable. Alteogen's position is that a strategic approach is needed since Regeneron, Eylea's original developer, and Bayer have built a tight patent network. In particular, in the US biosimilar market, patent disputes with originator companies often arise from the approval application stage.
This is because in the US, after a biosimilar approval application is filed, the originator drug developer is notified of the relevant materials, and a procedure is conducted in which both sides review patents that may be infringed. If the originator company asserts patent infringement during this process, litigation may follow separately from the approval. "Both Samsung Bioepis and Celltrion previously faced patent lawsuits of varying scale after receiving approval for their Eylea biosimilar products in the US," an industry official said.
The industry is paying attention to the fact that Alteogen is approaching this Eylea biosimilar business as a means of accumulating experience in the ophthalmology field rather than simply expanding revenue. The judgment is that experience in global clinical trials, approvals, regulatory response, and building ophthalmology sales networks can itself translate into competitiveness for future new drug development.
In fact, Alteogen Biologics, an Alteogen subsidiary, is developing "ALTS-OP01," a new drug substance for treating macular degeneration. ALTS-OP01 aims to secure differentiated competitiveness in the ophthalmic disease treatment field by improving the efficacy of existing therapies and extending dosing intervals. "Through the development of the Eylea biosimilar, we have accumulated significant know-how about the ophthalmology market and treatment needs," Alteogen CEO Jeon Tae-yeon said. "At the research stage, we are seeing favorable data compared to existing drugs, so we expect potential synergies with future ophthalmic drug development."
The company also views the biosimilar business as part of a process of transforming its corporate fundamentals. "Some view Alteogen as a company with only the ALT-B4 platform, but we are pursuing various projects including not only biosimilars but also obesity treatments and ophthalmic new drugs," Jeon said. "The very process of directly experiencing global clinical trials and approvals is an important asset for the company to advance to the next stage."
