FDA Accepts BLA for Samsung Bioepis' Trastuzumab Biosimilar

Republic of Korea-based Samsung Bioepis announced on Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB3, a proposed trastuzumab biosimilar, referenced on Herceptin. If the FDA approves SB3, the drug will be commercialized in the US by Merck.

In November 2017, Samsung Bioepis gained the European Commission’s marketing authorization for SB3, making the drug the first biosimilar trastuzumab to be approved in the European Union. The company will sell the drug as Ontruzant in the European Union and in the European Economic Area member states of Norway, Iceland, and Liechtenstein. Also in November, the company gained the Republic of Korea’s clearance to market SB3; in the Korean marketplace, the drug will be sold as Samfenet. Samsung Bioepis’ regulatory wins follow the company’s June 2017 announcement of positive data from a phase 3 study in patients with newly diagnosed with stage II to stage III primary breast cancer, as well as 1-year data announced in September.

If approved by the FDA, SB3 will compete not only with the reference Herceptin—which analysts believe could earn Roche subsidiary Genentech up to $6.4 billion in 2018—but also with Ogivri, Mylan—Biocon’s recently FDA-approved biosimilar trastuzumab. While Roche has reportedly reached an undisclosed agreement with Mylan concerning the launch of Ogivri in the US marketplace, Roche has vigorously defended its patents covering the reference Herceptin in the United States; Roche recently filed a lawsuit against another biosimilar developer, Pfizer, seeking to prevent a launch of a biosimilar trastuzumab in the US marketplace. (Although Pfizer has not announced submission of a BLA to the FDA, it has released positive data showing noninferiority of its PF-05280014 to the EU-licensed reference Herceptin.)

Samsung Bioepis reports a number of other biosimilar products in its product pipeline. The company is developing the following: SB4, etanercept (referenced on Enbrel); SB2, infliximab (referenced on Remicade); SB5, adalimumab (referenced on Humira); SB9, insulin glargine (referenced on Lantus); and SB8, bevacizumab (referenced on Avastin).