Biosimilars Month in Review: December 2024

The biosimilars month in review highlights a new ustekinumab (Stelara)biosimilar approved and an in-depth look at the field's progress in 2024.

New Ustekinumab (Stelara) Biosimilar Approved

FDA Approves Seventh Ustekinumab Biosimilar

The FDA has approved Celltrion’s CT-P43/ustekinumab-stba under the name Steqeyma, an ustekinumab biosimilar, for subcutaneous injection or intravenous infusion for both adult and pediatric patients with plaque psoriasis (PsO) and active psoriatic arthritis (PsA) as well as adults with Crohn disease (CD) and ulcerative colitis (UC). CT-P43 is expected to launch in February 2025.

Ustekinumab-stba marks the seventh ustekinumab biosimilar to get FDA approval. Ustekinumab is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23 and was originally approved over a decade ago for moderate to severe plaque psoriasis in adult patients.

Aflibercept Biosimilar Demonstrates Therapeutic Equivalence

Aflibercept Biosimilar Demonstrates Therapeutic Equivalence for DME

CT-P42, an investigational aflibercept biosimilar, has demonstrated therapeutic equivalence in people with diabetic macular edema (DME) in new phase 3 data.

Through week 24, there were similar improvements between participants treated with CT-P42 and reference aflibercept in change in BCVA and retinal central subfield thickness, and ETDRS Diabetic Retinopathy Severity Scale score. Pharmacokinetics, usability, and immunogenicity were comparable between groups, and in terms of safety, there were similar proportions of patients that experienced at least 1 treatment-emergent adverse event (CT-P42, 50.3%; reference aflibercept, 53.7%).

A Look at Biosimilar Progress in 2024

Multi-Stakeholder Collaboration Makes 2024 a Landmark Year for Biosimilars

Biosimilars have already made a difference in patient care and savings to the healthcare system and seem poised to make an even greater wave in the years to come. The continuing change is supported by efforts from physicians, advocates, companies, and the FDA; and patients, physicians, and even PBMs are starting to listen.

“Can we create an environment where incentives are aligned? …I think there's opportunities for shared savings, where another odd way, where users of biosimilars would be rewarded for using lower-cost therapies in terms of what they were able to share in terms of savings, I think looking towards pathways where we can ensure patients, youth who use biosimilars have lower co pays across the market, I think is certainly a benefit that we've learned from the generic market that could be applied to biosimilars,” Jon Martin, head of the US Biosimilar Unit at Organon, told HCPLive.