Fujifilm Kyowa Kirin Biologics (FKB)
Biosimilars
Background
Fujifilm Kyowa Kirin Biologics (FKB) began operations in March 2012 as a joint venture owned equally by Fujifilm Corporation and Kyowa Hakko Kirin, Ltd. (KHK). The joint venture combined Fujifilm’s advanced production, quality control and analytical technologies developed through its photographic film business with KHK’s proprietary technologies and know-how accumulated through its biopharmaceutical R&D and manufacturing experience. In April 2013, the Phase I trial of FKB 327 (adalimumab biosimilar), the lead biosimilar compound, was initiated.
Objective
In June 2013, KHK, acting on behalf of FKB, appointed Plexus Ventures to conduct a global out-licensing process to place FKB327 with a company capable of commercializing the product, with priority given to the highly regulated markets of the US and EU countries.
Process
In September 2013, Plexus Ventures contacted over 40 global companies chosen for their known interest in biosimilars and/or presence in autoimmune therapy. A number of the companies submitted non-binding offers and were admitted to due diligence. However, the terms offered by bidding companies failed to meet FKB’s target, due in part to the risk presented by the untested regulatory pathway for biosimilars in the US, and the absence of Phase 3 data for FKB327.
In October 2016, FKB announced the achievement of the primary endpoint in the Phase 3 trial. With this validation, a second out-licensing process was initiated which focused on the European territory where the regulatory pathway was more established.
Outcome
The second licensing process generated multiple attractive offers for the EU market, aided by EMA’s agreement to review the MAA in May 2017. In April 2018, FKB announced that EU rights had been granted to Mylan.
Following EMA approval of the MAA in September 2018, Mylan launched Hulio™ (biosimilar adalimumab) one month later. After the successful European launch, Mylan secured global rights to Hulio™ in February 2019.