Eye on Pharma: Daewoong Launches Samsung Bioepis' Trastuzumab Biosimilar

According to Korean news media, Daewoong Pharmaceutical, a Korean-based bioengineering company, announced yesterday that it has launched a trastuzumab biosimilar the Republic of Korea, sold as Samfenet. Daewoong secured exclusive sales rights for the biosimilar from drug developer, Samsung Bioepis in December 2017.

The trastuzumab biosimilar is priced 29.5% below the list price for the trastuzumab reference product, Herceptin, owned by Roche subsidiary Genentech. In 2016, Herceptin was the world’s eighth best-selling drug, with global sales of $6.7 billion. With the addition of Samfenet, Daewoong strengthens its oncology product portfolio that currently includes a chronic myeloid leukemia treatment, Supect (radotinib), and a prostate cancer drug, Luphere Depot (leuprolide acetate).

Samfenet will not be the only trastuzumab biosimilar available in the Korean market, as Celltrion launched its own biosimilar molecule, Herzuma, in September 2017. At the time of the first biosimilar’s launch, the list price of the originator Herceptin dropped to 70% of its original price, as is the case automatically after all first biosimilar market entries in the Republic of Korea.

In addition to the Korean market, Samsung Bioepis has its eyes on both the European and United States markets for the biosimilar. In December 2017, Bioepis announced that the FDA accepted its Biologics License Application (BLA) for review. If approved, the drug will be commercialized in the United States by Merck, and would compete not only the reference product, but also with Ogivri, Mylan-Biocon’s recently FDA-approved biosimilar trastuzumab (though Ogivri has yet to be launched, and no date for its launch has been publicized).

In the European Union, in November 2017, the European Commission granted Samsung Bioepis a marketing authorization for the biosimilar, making it the first trastuzumab biosimilar approved in that marketplace. Within both the EU and the European Economic Area member states of Norway, Iceland, and Liechtenstein, the drug will be sold as Ontruzant.

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