Sam Chun Dang Pharm. Co., Ltd. reshapes its Eylea biosimilar strategy in Japan... “Will hold marketing approval directly”

[Financial News] Sam Chun Dang Pharm. Co., Ltd. has reshaped its Eylea biosimilar business in Japan. It has ended its relationship with its existing sales partner and joined forces with a Daiichi Sankyo affiliate, switching to a structure in which it holds the marketing authorization directly. The strategy is to entrust local sales to a partner while securing the core rights itself, thereby strengthening its control over the business and its future negotiating leverage.
According to Sam Chun Dang Pharm. Co., Ltd. on the 2nd, the company signed an exclusive sales and supply agreement in Japan with Daiichi Sankyo Espha (DSE) for SCD411, a biosimilar of Eylea (generic name: aflibercept), a treatment for age-related macular degeneration. However, it mutually agreed to terminate its contract with its existing partner, Senju Pharmaceutical.
The key change in this agreement is who holds the marketing authorization. Under the previous contract with Senju Pharmaceutical, the local partner held the authorization. Under the new agreement, Sam Chun Dang Pharm. Co., Ltd. secured the authorization in its own name through Japan’s special approval system for foreign manufacturers.
As the designated marketing authorization holder (D-MAH), DSE will handle local exclusive sales and promotion of SCD411 2mg prefilled syringes (PFS) and vials, as well as maintaining the marketing authorization.
Holding the marketing authorization directly could broaden the company’s options if it changes local partnerships or its business strategy in the future. However, as the sales terms and profit-sharing structure have not been disclosed, further information is needed to determine whether the agreement will actually improve profitability.
Industry observers say, “Who holds the marketing authorization in a biosimilar business is a factor that affects long-term business operations and negotiating leverage,” and assess that “business performance will be determined more by local sales and profit-sharing terms than by securing the authorization itself.”
Meanwhile, Sam Chun Dang Pharm. Co., Ltd. is pursuing a plan to make DSE its sole partner in Japan for products based on its proprietary oral drug-delivery platform, S-PASS. The aim is to expand cooperation beyond biosimilars to include its follow-on pipeline.
A representative of Sam Chun Dang Pharm. Co., Ltd. said, “This agreement is not simply a change of sales partner; it has restructured the rights framework for our business in Japan,” adding, “Now that we hold the marketing authorization directly, we will leverage our local commercialization capabilities and focus on expanding the market.” 


[email protected] Kim Kyung-a Reporter