FDA approves Ontruzant, a third trastuzumab biosimilar

The US Food and Drug Administration on Friday approved South Korean firm Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar trastuzumab referencing Swiss pharma giant Roche’s (ROG: SIX) Herceptin, for the treatment of HER2-positive breast cancer and HER2 over-expressing gastric cancer.

The drug was first approved by the European Medicines Agency in November 2017, making it the first biosimilar trastuzumab to be approved in the European Union. Since the approval, Europe has also seen the entry of three additional versions of biosimilar trastuzumab, Herzuma, Kanjinti, and Ogivri.

Under an agreement with Samsung Bioepis, Ontruzant will be commercialized in the USA by US pharma giant Merck & Co (NYSE: MRK).

Ontruzant will now compete in the USA with the reference product, Herceptin, which in the first nine months of 2018 generated sales of $5.31 billion globally for Roche. The newly approved biosimilar will also eventually compete with two prior FDA approved biosimilars: Ogivri, developed by Mylan (Nasdaq: MYL) and India’s Biocon (BSE: 532523), and Herzuma, developed by Celltrion (Kosdaq: 068270). To date, no trastuzumab biosimilars have launched in the USA, and Roche has reportedly reached an undisclosed accord with Mylan concerning the launch of Ogivri in the USA.