FDA holds back Alvotech’s Humira biosimilar over manufacturing issues

The Food and Drug Administration has rejected an application from Alvotech for approval of the Iceland-based drugmaker’s copycat version of AbbVie’s top-selling Humira.

In a statement Monday, Alvotech said the FDA had informed it that deficiencies in the company’s manufacturing plant in Reykjavik need to be corrected before it can launch the drug in the U.S.