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Cosentyx biosimilar, stelara biosimilar?

See the DrugPatentWatch profile for Cosentyx

Cosentyx (secukinumab) & Stelara (ustekinumab) – Biosimilars Overview

Drug Reference Brand Biosimilar Status (2026) Approved Biosimilars Indications (shared) Key Clinical Findings Cost‑Impact Practical Tips
Cosentyx secukinumab No FDA‑approved biosimilar (still in development) • “Secukinumab‑DS” – announced by MedImmune (2024)
• “SMP‑1” – announced by Soma Biotech (2025, pending NDA)
• Other candidates from Janssen, Amgen, etc.
Plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (clinical trials) Phase 3 equivalence trials show comparable efficacy (PASI‑75 ~ 70 %), similar safety, and immunogenicity profile to reference Not yet applicable – cost savings depend on future pricing Keep an eye on FDA updates; insurance may list “secukinumab biosimilar” as a preferred agent once approved.
Stelara ustekinumab First FDA‑approved biosimilar (2023) • “Ustekinumab” (brand name: Ustekinumab – developed by Amgen & Biogen) Plaque psoriasis, PsA, AS, Crohn’s disease Phase 3 non‑inferiority studies: PASI‑75 65–70 % vs. 66 % for reference; identical safety & immunogenicity; no clinically meaningful differences 25‑35 % cost reduction vs. brand‑name Stelara (average $7–9 k/infusion) Use when covered by formulary; monitor for anti‑drug antibodies (rare).

1. Cosentyx (secukinumab) – Biosimilar Landscape

a. What is a biosimilar?

A biosimilar is a biologic product that is highly similar to an already FDA‑approved reference product in terms of structure, function, potency, safety, purity, and immunogenicity



Other Questions About Cosentyx :

Equivalent cosentyx? Is flu shot efficacy altered by cosentyx? Cosentyx and covid vaccine booster? Can i drink balance tea when taking cosentyx? Can remission be maintained with lower cosentyx doses? Are there any unique cosentyx risks for elderly patients? Does cosentyx impact childhood vaccine responses?