Eye on Pharma: Daiichi Sankyo Launches Biosimilar Trastuzumab in Japan

Earlier this week, Daiichi Sankyo announced that it has launched its biosimilar trastuzumab, trastuzumab BS, referencing Herceptin, in Japan.

In 2016, Daiichi Sankyo and Amgen entered into an exclusive biosimilar commercialization agreement. Under the agreement, Daiichi Sankyo would be responsible for filing for marketing approval as well as the distribution and commercialization of 9 biosimilars in Japan, while Amgen took over the development and manufacturing responsibilities.

The biosimilar trastuzumab was approved by the Pharmaceuticals and Medical Devices Agency on September 21, 2018, and is indicated for intravenous drip infusions at 60 mg and 150 mg for the treatment of breast cancer with human epidermal receptor 2 (HER2) overexpression, and unresectable advanced or relapsed gastric cancer with HER2 overexpression.

This marks the first biosimilar product launched by Daiichi Sankyo. “The company expects that the product will provide patients and medical professionals with various options for cancer treatment,” according to a company statement.

To date, the European market has seen the launches of 3 biosimilar trastuzumab products, sold as Ontruzant, Herzuma, and Kanjinti. While the FDA approved the first and only US-licensed biosimilar trastuzumab—Ogivri—nearly 1 year ago, it has yet to enter the US market, and no launch date has been made publicly available by sponsor Mylan.

Herceptin, developed by drug maker Roche, earned the company nearly $7,028,00 globally in 2017, making the medicine Roche’s second top-selling product.