STADA and Xbrane advance Lucentis biosimilar candidate

German drugmaker STADA Arzneimittel (SAZ: Xetra) and its biosimilar development partner Swedish firm Xbrane Biopharma (Nasdaq OMXS: XBRANE) have announced that their ranibizumab biosimilar candidate met its primary endpoint in a pivotal comparability trial involving 583 patients.

On the basis of these six-month interim results from the Phase III-type ‘Xplore’ clinical trial, the two companies anticipate submitting a Marketing Authorization Application (MAA) to European Medicines Agency (EMA) and a Biologics License Application (BLA) to US Food and Drug Administration (FDA) during the second half of 2021.

In the randomized, double-masked, multicenter study, the ranibizumab biosimilar candidate met the primary endpoint demonstrating equivalent efficacy in BCVA (Best Corrected Visual Acuity) at Week 8 of treatment compared to the reference biologic, Lucentis, which is marketed by Roche (ROG: SIX) in the US and Swiss rival Novartis (NOVN: V) elsewhere.

Furthermore, the interim analysis of six-month data demonstrated that the biosimilar has similar pharmacokinetic, safety and immunogenicity profile compared to Lucentis, a VEGF-α inhibitor used in treatment of serious eye diseases, mainly wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).