logo
Plus   Neg
Share
Email

FDA Okays Amgen And Allergan's Kanjinti, Biosimilar To Herceptin

Amgen (AMGN) and Allergan plc (AGN) said that the U.S. Food and Drug Administration approved Kanjinti or trastuzumab-anns for all approved indications of the reference product, Herceptin or trastuzumab for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Amgen has a total of 10 biosimilars in its portfolio, three of which have been approved in the U.S. and three that are approved in the European Union.

The company said that Kanjinti is currently not available commercially.

In the U.S., KANJINTI is approved for Adjuvant Breast Cancer, Metastatic Breast Cancer, Metastatic Gastric Cancer.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Department of Justice has reached a settlement agreement with a Texas-based Taco Bell franchise owner for immigration-related discrimination against certain employees. The settlement resolves the DOJ's investigation into whether MUY Brands LLC, and a related management company, MUY Consulting Inc., violated the Immigration and Nationality Act. Starbucks is gearing up for the upcoming holiday season by introducing its 2019 holiday flavors in U.S. grocery stores. The launch of the coffee giant's holiday line-up this year includes returning holiday favorites as well as a new item. Customers can now take home products that are making a comeback such as Starbucks Holiday Blend K-Cup and Ground Coffee, Peppermint Mocha Flavored Ground Coffee, Peekay International issued a recall of 7 ounce and 14 ounce packs containing Keshav Dry Apricot food treats as they contain undeclared allergens such as sulfites, according to a statement published by The U.S. Food and Drug Administration. Consumption of the product by those allergic or having severe sensitivity to sulfites could run the risk of serious or life-threatening allergic reactions.
Follow RTT
>