Biosimilars Month in Review: November 2024

The biosimilars month in review highlights a new denosumab (Prolia, Xgeva) biosimilar coming close to approval and new equivalency data supporting denosumab and tocilizumab (Actemra) biosimilars.

New Denosumab (Prolia,Xgeva) Biosimilar up for Approval

FDA Accepts BLA for Denosumab Biosimilar

The FDA has accepted Organon and Shanghai Henlius Biotech’s biologics license application for HLX14, a denosumab biosimilar. The BLA is based on data from comparative quality analytical studies and 2 clinical studies, among other head-to-head studies for HLX14, that demonstrated comparable efficacy, safety, tolerability, and immunogenicity of HLX14 with reference PROLIA in postmenopausal women with osteoporosis at high risk for fracture.

Denosumab is FDA-approved to treat postmenopausal women at high risk for fracture, patients with intolerance or inadequate response to other osteoporosis treatments, and patients who will be taking corticosteroids for ≥6 months and are at a high risk for fracture. The drug is also used to increase bone mass in men with osteoporosis at a high risk for fracture and men at a high risk for fracture treated with certain medications for prostate cancer.

New Equivalency data for Tocilizumab, Denosumab Biosimilars

Tocilizumab Biosimilar Demonstrates Similar Safety, Efficacy for RA to Reference

CT-P47, a tocilizumab (Actemra) biosimilar, has demonstrated similar efficacy, pharmacokinetics, safety, and immunogenicity to reference (ref) tocilizumab in a phase 3 single transition study, in data presented at the American College of Rheumatology (ACR) Convergence 2024, held in November in Washington, DC.

In 412 participants receiving maintenance tocilizumab, maintenance CT-P47, or switching from tocilizumab to CT-P47, mean change from baseline of DAS28 was not affected by the transition from ref-tocilizumab to CT-P47 at Week 24. Comparable improvements in clinical activity were observed up to Week 52 as measured by American College of Rheumatology 20/50/70 responses and remissions by clinical disease activity index, simplified DA, and Boolean-definitio

Tocilizumab is approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

Denosumab Biosimilar Demonstrates Equivalent Efficacy, Safety in Phase 3 Trial
CT-P41, a proposed denosumab biosimilar, has demonstrated further favorable data compared to reference denosumab in postmenopausal women with osteoporosis, in data also presented at the 2024 ACR Convergence.

Investigators found that in 422 participants randomized at Week 52 to CT-P41 maintenance (n = 221), denosumab maintenance (n = 100),or switch to CT-P41 (n = 101), mean percent change of bone mineral density BMD) for the lumbar spine, total hip, and femoral neck increased from baseline until week 78 comparably among groups. One patient (0.5%) had a new vertebral fracture in the CT-P41 maintenance group at Week 78. Nonvertebral fractures were reported in 2 (0.9%) patients in the CT-P41 maintenance group and 1 (1.0%) patient in the switch to CT-P41 group. No hip fracture was reported.

Additional data on CT-P41 were also presented that demonstrated no impact of anti-drug antibody (ADA) status on pharmacokinetics, efficacy, or safety in any of the study groups.