FDA OKs Hu­mi­ra copy­cat from Mer­ck, Sam­sung Bioepis — but they will wait 4 years to launch

Mer­ck and Sam­sung Bioepis clinched the FDA’s en­dorse­ment of their Hu­mi­ra biosim­i­lar, Hadli­ma, adding a key mar­ket to the list of coun­tries where they have gained ap­proval.

Now they just have to count down to the launch date ne­go­ti­at­ed with Ab­b­Vie: June 30, 2023.

Per IP set­tle­ments, Hadli­ma will be the sec­ond Hu­mi­ra knock­off to en­ter the US com­mer­cial scene, af­ter Am­gen but be­fore My­lan and San­doz field their own prod­ucts.

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