Sandoz’s Biosimilar Application Accepted – Big Molecule Watch

Sandoz recently announced that the EMA (European Medicines Agency) has accepted its application for a 100 mg/ml citrate-free formulation of its biosimilar HYRIMOZ® (adalimumab).  The indications covered in the application include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and uveitis.  According to the press release, Sandoz has conducted a Phase I pharmacokinetics (PK) bridging study comparing the high concentration formulation to the 50 mg/ml HYRIMOZ® product, which demonstrated comparable pharmacokinetics and showed similar safety and immunogenicity profiles between the two.   The lower concentration HYRIMOZ® formulation was approved by the EMA on July 26, 2018.