BRIEF—EC nod for Sandoz' biosimilar Hyrimoz

Following approval last month from the US regulator, Sandoz has now received European Commission (EC) marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100mg/mL) of its biosimilar Hyrimoz (adalimumab), referencing AbbVie’s mega-blockbuster Humira.

The approval includes all indications covered by Humira: 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, a unit of Swiss pharma giant Novartis.

“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. Today’s 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,” she added.