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For Immediate Release

2019.12.19

Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Sunao Manabe, Representative Director, President and CEO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Junichi Onuma,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
https://www.daiichisankyo.com

Daiichi Sankyo Launches Antitumor Agent Bevacizumab Biosimilar for Intravenous Drip Infusions “Daiichi Sankyo” in Japan

Tokyo, Japan (December 19, 2019) - Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has launched the antitumor agent bevacizumab BS for intravenous drip infusions 100 mg and 400 mg “Daiichi Sankyo” (generic name: bevacizumab (genetical recombination) [bevacizumab biosimilar 2], hereafter, “the product”) today in Japan.

 

The product is a pharmaceutical agent developed by Amgen Inc. (Headquarters: Thousand Oaks, CA, U.S.A; hereafter, “Amgen”) as a biosimilar product to the anti-VEGF humanized monoclonal antibody, bevacizumab. The product was approved on September 20, 2019, and indicated for unresectable advanced or recurrent colorectal cancer.

 

Based on the exclusive agreement on the commercialization of biosimilars concluded with Amgen in July 2016, Daiichi Sankyo is responsible for the distribution and commercialization of the product in Japan, while Amgen is responsible for its manufacture.

 

Daiichi Sankyo expects that the product will provide patients with various options for cancer treatment, thereby further contributing to medical treatment in japan.

 

 

 Product name

 Bevacizumab BS for intravenous drip infusions 100 mg and 400 mg “Daiichi Sankyo”

 Generic name

 Bevacizumab (Genetical Recombination)[ Bevacizumab Biosimilar 2]

 Indications

 Unresectable advanced or recurrent colorectal cancer.

 Dosage and administration

 In combination with other antineoplastic agents, adults are usually infused intravenously
 at 5 mg / kg (body weight) or 10 mg / kg (body weight) once as bevacizumab (genetical   recombination) bevacizumab biosimilar 2]. Dosing interval should be 2 weeks or more.

 Date of approval for   manufacturing and   marketing

 September 20, 2019

 Date of listing in the
 NHI reimbursement

 November 27, 2019

 Day of launch

 December 19, 2019

 Marketing authorization   holder

 DAIICHI SANKYO COMPANY, LIMITED

 Partner

 Amgen Inc.

 

About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.