Sandoz receives US FDA approval for biosimilar Hyrimoz(TM) (adalimumab-adaz)

Biosimilar Hyrimoz^TM (adalimumab-adaz) approved for all indications of reference medicine not protected by orphan exclusivity **. Biosimilars are critical to sustaining US healthcare system, providing broader access to vital treatments for prevalent chronic conditions such as psoriasis and rheumatoid arthritis, which affect over eight million Americans combined Hyrimoz is third FDA-approved Sandoz biosimilar in US Holzkirchen, Germany, October 31, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar, Hyrimoz^TM (adalimumab-adaz). The FDA granted approval for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) in patients four years of age and older, psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn's disease (CD), ulcerative colitis (UC) and plaque psoriasis (Ps). "Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease," said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. "With the FDA approval of Hyrimoz, Sandoz is one step closer to offering US patients with autoimmune diseases the same critical access already available in Europe." The FDA approval of Hyrimoz was based on a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that Hyrimoz matches the reference biologic in terms of safety, efficacy and quality.