January 29, 2020

Samsung Bioepis wins 4th FDA approval for biosimilar

PUBLISHED : July 24, 2019 - 10:23

UPDATED : July 24, 2019 - 10:23

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South Korean pharmaceutical firm Samsung Bioepis said on July 24 it has won approval from the US Food and Drug Administration to sell one of its biosimilars in the United States.

Hadlima, referencing AbbVie’s blockbuster autoimmune treatment Humira, can be also used for treatment of diseases that include rheumatoid arthritis, psoriasis, ulcerative colitis and uveitis.

However, it is undecided when Hadlima will go on sale in the United States as the patent for Humira is to expire in 2023.

It is the fourth Samsung Bioepis biosimilar to receive the green light from the FDA. It is already selling Renflexis, a biosimilar of Janssen Biotech’s blockbuster immunology medicine Remicade; Ontruzant, a biosimilar product referencing Switzerland-based Roche Holding’s Herceptin, also known as Trastuzumab; and Etanercept, a biosimilar referencing the immunology drug Enbrel developed by US-based Amgen, in the US.

By Ram Garikipati and newswires (

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