On December 18, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported 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 (Press release, Daiichi Sankyo, DEC 18, 2019, View Source [SID1234552464]).

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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