Sandoz gets European Commission nod for Hyrimoz high-concentration formulation
Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a).;
Basel: Sandoz has announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz (adalimumab).
The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa.
“Living with a chronic disease can take a significant toll on a patient’s quality of life. Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz.
“With eight marketed biosimilars Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe with more than two decades of experience. This approval brings Sandoz one step closer to providing European patients with chronic conditions an additional treatment option that offers increased convenience and a reduction in injection volume.”
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