STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK
On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK's Medicines and Healthcare product Regulatory Agency (MHRA) has granted marketing authorization for XIMLUCI (ranibizumab), a biosimilar of LUCENTIS. XIMLUCI is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders which affect nearly 1.5 million people in the UK. XIMLUCI was previously granted marketing authorization in the EU last November and, according to the press release, Stada is prepared to be launch the product in the UK in 2023.
Sandoz Receives Positive CHMP Opinion for Citrate-Free High Concentration Formulation of Adalimumab Biosimilar
On January 30, 2023, Sandoz announced receiving a positive opinion for marketing authorization for its citrate-free high concentration formulation (HCF) of HYRIMOZ (adalimumab) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The authorization includes all indications covered by HUMIRA, the reference product: rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and uveitis. According to Sandoz, its citrate-free HCF (100mg/mL) formulation will decrease injection volume and potentially decrease number of injections compared to the 80 mg/mL dosing while maintaining the same auto-injector as currently offered.
Sandoz's HYRIMOZ 50 mg/mL product was first approved by the European Commission in July 2018 and launched in several European countries shortly thereafter. Sandoz states that the submission of its citrate-free HCF formulation to the EMA included comparable pharmacokinetics results, and similar safety and immunogenicity between the 100mg/mL HCF to the approved 50 mg/mL product.
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