Alteogen's biosimilar proves similarity to Eylea

South Korea’s Alteogen said on Wednesday its investigational biosimilar ALT-L9 has demonstrated similarity to the originator Eylea (aflibercept) with no significant side effects in non-clinical studies in the U.S.

Shares of Kosdaq-listed Alteogen ended Wednesday at 24,150 won ($22.57), up 4.09 percent from the previous session.

The comparison test was conducted at Michigan-based bioanalytical agency MPI Research for nine months. Eylea and ALT-L9 were injected into monkey eyes every four weeks four times. At week 13, the head to head analysis showed the investigational drug is similar to the originator in efficacy and safety. Alteogen said that ALT-L9 was developed with its own composition and formulation technology and it is very meaningful that the drug’s similarity with safety has been proven under a different formulation.

Alteogen said it will start global clinical trials upon receiving an official report on the animal test result. Alteogen signed a contract with Japan’s Kissei Pharmaceutical in February 2014 for co-development and marketing of ALT-L9 with a goal to sell the biosimilar in Japan and China from 2022 when Eylea’s material patent goes off.

Eylea is Regeneron’s blockbuster indicated for treatment of wet macular degeneration. Eylea sales are estimated to hit $6.5 billion this year, according to EvaluatePharma.

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