News | December 19, 2019

Daiichi Sankyo Launches Antitumor Agent Bevacizumab Biosimilar For Intravenous Drip Infusions ‘Daiichi Sankyo' In Japan

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, visit www.daiichisankyo.com.

Source: Daiichi Sankyo Group