Mycenax said it is expected to apply for a Japanese PMDA license for its macular disease injectable biosimilar, Eylea, developed in collaboration with Korean eye drug manufacturer SCD, in the first half of next year (2023).

Eylea, a biosimilar drug for eye diseases developed by Korean eye drug manufacturer SCD, has completed its Phase III clinical trial and is currently compiling relevant documentation. 

The biosimilar is available in two dosage forms, with Mycenax being responsible for the production of all the APIs and the filling of one of the dosage forms, while the other dosage form is filled and packaged aseptically by Adimmune.

Mycenax said it has completed the process validation of the biosimilar and is actively cooperating with the customer for factory inspection and pre-marketing preparations.

In addition to the Japanese market, SCD signed an exclusive sales contract with a foreign pharmaceutical company in November this year to supply 15 European countries, and the contract is expected to be completed in February next year.

As far as we know, SCD is aiming for a 15% global market share with an annual sales volume of 2.4 million doses.