Sandoz receives positive opinion for citrate-free high concentration Hyrimoz® (adalimumab)

The CHMP adopted a positive opinion recommending the approval of a citrate-free high concentration formulation of Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira®.  The positive opinion relates to all indications in the reference product, Humira®.  Hyrimoz was first approved in the EU in July 2018, and Sandoz is seeking to expand its approved indications to those of Humira.