Centus Biotherapeutics Receives European Marketing Authorization forEquidacent®, Biosimilar Avastin®
LONDON and TOKYO, Sep. 29th, 2020― Centus Biotherapeutics Ltd., a joint venture betweenFujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca, today announced that the EuropeanCommission (EC) has granted the marketing authorization for Equidacent® (Product Code:FKB238), the company’s biosimilar to Avastin® (bevacizumab).
The authorization follows the adoption of a positive opinion by the Committee for Medicinal
Products for Human Use (CHMP), which concluded that the development program includinganalytical, functional, clinical, and immunogenicity data demonstrated biosimilarity with thereference product, Avastin®.
The EC approval of Equidacent® applies to 27 European Union (EU) member states, the United
Kingdom (UK) and the European Economic Area (EEA) member states of Norway, Iceland, andLiechtenstein.
Equidacent® is indicated for the following indications:
metastatic carcinoma of the colon or rectum
metastatic breast cancerunresectable advanced, metastatic, or recurrent non-small cell lung canceradvanced and/or metastatic renal cell cancerepithelial ovarian, fallopian tube, or primary peritoneal cancerpersistent, recurrent, or metastatic carcinoma of the cervix
Fujifilm Kyowa Kirin Biologics President and CEO Atsushi Matsumoto, Ph.D. commented, "We
are proud that Centus received the approval of Equidacent® from the European Commission.
This demonstrates that Fujifilm Kyowa Kirin Biologics successfully utilized its deep scientificexpertise needed to develop biosimilars in collaboration with AstraZeneca."
Centus was established in 2015 as a joint venture between Fujifilm Kyowa Kirin Biologics andAstraZeneca. Fujifilm Kyowa Kirin Biologics has granted an exclusive license to Centus for thedevelopment, manufacture, and commercialization of Equidacent® on a worldwide basis. Centus
has been proceeding with clinical development of Equidacent®.
Data submitted to obtain the marketing authorization for Equidacent® included similarity
assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity
to the bevacizumab reference product, Avastin®. The phase 3 clinical study, AVANA, conductedby Centus, demonstrated no clinically meaningful differences in terms of safety, efficacy, andimmunogenicity compared with the reference product, Avastin®, in non-small cell lung cancerpatients.

About Bevacizumab
Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by
inhibiting vascular endothelial growth factor A (VEGF-A). It reduces growth and metastasis ofseveral solid tumors.
About Centus
Centus Biotherapeutics (Centus) founded in 2015 is a joint venture between AstraZeneca, a
global pharmaceutical leader, and Fujifilm Kyowa Kirin Biologics, a Japanese biopharmaceuticalcompany focused on biosimilar development.
With the unique coupling of world class biologics expertise, global commercial infrastructure anddeep biosimilar development experience, Centus is well positioned to win the trust of doctors
and serve the needs of patients worldwide.
For more information please visit: https://www.centusbiotherapeutics.com
About Fujifilm Kyowa Kirin Biologics
Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President: Kenji
Sukeno; “Fujifilm”) and Kyowa Kirin Co., Ltd. (President and CEO: Masashi Miyamoto, “KyowaKirin”) on March 27, 2012 as a company for developing, manufacturing, and marketingbiosimilars. Its pipeline includes Equidacent® and Hulio®, an adalimumab biosimilar (ProductCode: FKB327), a drug to treat a range of inflammatory diseases.
By merging the technologies in advanced production, quality control, and analysis which Fujifilm
has developed over many years through its photographic film business, with the proprietary
technologies and know-how which Kyowa Kirin has accumulated through its biopharmaceutical
R&D and manufacturing, Fujifilm Kyowa Kirin Biologics creates revolutionary production
processes and reduces costs for the production of biosimilars. Through this partnership, thecompany will develop and manufacture reliable, high quality, and cost-competitive biosimilar
products, and will commercialize these products in a timely manner. With this strategy, Fujifilm
Kyowa Kirin Biologics aims to hold a leading position in the expanding biosimilar market.
You can learn more about the business at: fujifilmkyowakirin-biologics.com

For inquiries on information in this media release, contact:
Fujifilm Kyowa Kirin Biologics
Ryohei Kawai
Kyowa Kirin Co., Ltd (for Fujifilm Kyowa
Kirin Biologics)+81-3-5205-7205
Email: media@kyowakirin.com
Takuro Nishijima
FUJIFILM Holdings Corporation (for FujifilmKyowa Kirin Biologics)+81-3-6271-2000