On June 14th, Biocad presented Week 14 results on the safety and efficacy of BCD-055 (infliximab biosimilar) from the ongoing Phase III LIRA clinical trial. The international, multicenter, double-blind, placebo-controlled trial randomised (2:1) 426 adult patients with active rheumatoid arthritis (RA) to receive BCD-055 or infliximab innovator for 54 weeks both at a dose of 3mg/kg. At Week 14, 71.6% of patients receiving BCD-055 compared with 67.9% of patients receiving Remicade achieved American College of Rheumatology 20% improvement criteria (ACR20) (p=0.587).
In addition, both groups demonstrated a significant decrease in Disease Activity Score 28 – C reactive protein (DAS28-CRP) and no differences in safety profiles. Although BCD-055 is on its way to showing therapeutic equivalence to Remicade through Week 54, Biocad will face competition from numerous other intravenous (IV) infliximab biosimilars, including Celltrion’s Inflectra, Pfizer’s Ifixi, and Biogen’s Flixabi to name a few.
Focusing on the competition within the biosimilar space, Celltrion appears to be ahead of the crowd developing the first ever subcutaneous (SC) formulation of an infliximab biosimilar. Celltrion’s IV CT-P13, marketed as Inflectra, has proven to be effective and well tolerated compared with Remicade. At the 2018 EULAR conference, Celltrion presented positive Phase I/III clinical data on SC CT-P13 marking the potential for Celltrion to provide RA patients with a more convenient, self-injectable infliximab biosimilar.
In the Phase I/III clinical trial, 48 patients with RA were randomised to receive CT-P13 SC (90mg, 120mg, or 180mg) or CT-P13 IV (3mg/kg) at Week 6 following an initial dose of CT-P13 IV (3mg/kg) at Week 0 and 2. At Week 30, 84.6% (n=13), 90.9% (n=11), 83.3% (n=10), and 100% (n=12) of patients receiving CH-P13 IV and CH-P13 SC (90mg, 120mg, and 180mg) achieved ACR20, respectively.
In addition, improvement in DAS28-CRP was comparable across all four treatment groups regardless of route of administration or dosage. The SC formulation also demonstrated a similar safety profile to the IV formulation marking strong potential for Celltrion to set itself apart in the crowded infliximab biosimilar space.
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