Biosimilars Month in Review: September 2024

The biosimilars month in review highlights a new approval of an ustekinumab (Stelara) biosimilar and cost savings of biosimilars in 2023. New data also further support the equivalence of biosimilars.

New Approval of Ustekinumab (Stelara) Biosimilar

FDA Approves Stelara Biosimilar Ustekinumab-aauz (Otulfi)

The FDA has approved Fresnius Kabi and Formycon’s ustekinumab biosimilar, ustekinumab-aauz (Otulfi), in both its subcutaneous and intravenous formulations for treating Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis (PsA), the same indications as reference ustekinumab (Stelara; Johnson & Johnson).

The approval was based off of data demonstrating comparable efficacy, safety, pharmacokinetics and immunogenicity to reference ustekinumab and marks the fourth biosimilar approved for ustekinumab, for all approved indications.

New Data Support Equivalence of Biosimilars

A secukinumab biosimilar has demonstrated pharmacokinetic equivalence to the reference drug and new data has supported the biosimilarity of an aflibercept biosimilar to the reference drug.

52-Week Data Support MYL-1701P as Aflibercept Biosimilar for DME

Treatment with MYL-1701P, an aflibercept biosimilar, was backed by new data from the Phase 3 INSIGHT randomized clinical trial, suggesting its benefit as an alternative to reference aflibercept in eyes with diabetic macular edema (DME).

First approved by the FDA in 2011, aflibercept (Eylea) has been indicated for the treatment of neovascular age-related macular degeneration (AMD), DME, and macular edema from retinal vein occlusion (RVO), diabetic retinopathy (DR), and retinopathy of prematurity (ROP).

Secukinumab Biosimilar Demonstrates Pharmacokinetic Equivalence

CMAB015, a secukinumab biosimilar, has demonstrated equivalent pharmacokinetics (PK) and comparable safety and immunogenicity to the reference drug in a double-blind study (NCT05734482) in healthy male participants conducted in China.

Investigators found that the geometric mean ratio (GMR) for CMAB015/secukinumab was 104.05% for Cmax and 95.70% for AUC0-inf, with 90% confidence intervals (Cis) within the bioequivalence limits of 80.00–125.00%. CMAB015 also had a comparable safety profile to reference secukinumab and participants experienced no serious adverse events (AEs).

Biosimilars Provided Billions of Cost Savings in 2023

Biosimilars Saved $12.3 Billion in 2023, a Fraction of Potential Savings

Savings from the use of biosimilar medicines reached $12.4 billion in 2023, according to the Association for Accessible Medicines’ and Biosimilars Council’s 2024 U.S. Generic & Biosimilar Medicines Savings Report.

Although generic and biosimilar prescriptions account for 90% of prescriptions filled in the U.S., they account for only 13.1% of the country’s spending on prescription drugs. In terms of overall healthcare spending, generics and biosimilar medicines represent only 1.2% of total spending in the U.S. Looking more specifically at healthcare savings, biosimilar usage generated $137 billion in savings in Medicare and $206 billion in commercial health plan savings.