Humira biosimilar approval comes with four year wait for launch

24 July 2019

The US approval of a biosimilar referencing Humira (adalimumab) marks a significant approval for Korean drug developer Samsung Bioepis, but will mean little for patients until July 2023 – when the product can actually be launched.

Samsung Bioepis, which is a joint venture involving Samsung BioLogics and US biotech Biogen (Nasdaq: BIIB), has become the first company to receive US approvals for biosimilars referencing all three first-generation anti-TNF medicines.

And it is the company’s fourth biosimilar to be approved in the USA as a whole, following in the footsteps of copies of Remicade (infliximab), Herceptin (trastuzumab) and Enbrel (etanercept).

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