Adimmune Corporation (4142) announced the signing of an agreement with SCD, a leading ophthalmic drug manufacturer in Korea, for developing and manufacturing a biosimilar of Eylea, an intravitreal injection solution for macular degeneration. Taking advantage of Adimmune’s cutting-edge aseptic fill and finish line and international collaboration experiences, SCD established a partnership with Adimmune to enter the biosimilar market and signed a 10-year agreement for manufacturing biosimilars. Adimmune has received an upfront payment and is expected to receive future milestone payments from SCD over the course of the drug development.
Adimmune pointed out that biosimilars are relatively affordable compared to their reference products; therefore, pharmas are encouraged by governments, with the objective to satisfy the needs of the public and reduce their financial burden, to bring forth biosimilars that are highly similar to the reference medicine. Eylea, for example, in Taiwan, costs around TWD 50,000 each dose, yet upon the launch of its biosimilar, the cost for medication is expected to be brought down significantly. SCD intends to initiate the phase III clinical trial of the biosimilar of Eylea in the second half of 2021 and to launch the drug before the patent of the brand drug expires. The biosimilar is expected to be available in Japan, Europe and the United States as early as 2024.
The partnership is based on SCD’s pressing need for an ally with expertise in novel process development and stable manufacturing capacity. Adimmune, which has acquired the certifications from USFDA, EMA, and passed plant inspection certification from Korea, will participate in the entire drug development from process development, phase III clinical trial, to product launch. Based on the agreement between Adimmune and SCD, after launching the biosimilar, orders no less than 1.4 million doses per year in the first three years are guaranteed. By starting the biosimilar business, Adimmune can expect high gross margin and further expansion in its business overseas.
The biosimilar of Eylea is the first biosimilar in SCD’s portfolio. The brand drug is developed by Bayer and Regeneron. The global sales amount in 2018 was approximately USD 6.4 billion and ranked 8th in the global biologics sales. The USFDA has approved its uses for curing age-related macular degeneration and diabetic retinopathy.