Is a Generic Version of Cosentyx Available?
No, no generic version of Cosentyx (secukinumab) is available in the US or major markets as of 2024. Cosentyx is a biologic drug, so generics aren't possible—instead, biosimilars (similar but not identical copies) are the alternative. Novartis holds exclusivity, with no FDA-approved secukinumab biosimilars yet.[1]
When Could Biosimilars Launch?
US regulatory exclusivity for Cosentyx ends December 2025, potentially allowing biosimilar applications then. Patents extend protection longer: key ones expire around 2031-2036, including formulation and device patents.[2] European biosimilars may enter earlier; Alvotech filed for approval in 2023, targeting 2026 launch if approved.[1][2]
Who's Developing Cosentyx Biosimilars?
Multiple companies are in the pipeline:
- Alvotech (AVT02) completed phase 3 trials showing similarity to Cosentyx; FDA submission expected soon.
- Dong-A ST/Meiji Seika (BAT2206) finished trials, plans global filings.
- Intas Pharmaceuticals and others have candidates in development.[2]
Litigation is ongoing—Novartis sued Alvotech in 2023 over patents, delaying US entry.[2]
How Does Cosentyx Compare to Biosimilars?
Biosimilars match Cosentyx's efficacy and safety for psoriasis, psoriatic arthritis, and ankylosing spondylitis. Phase 3 data for AVT02 showed non-inferiority (similar PASI-90 response rates: 77% vs. 74% for Cosentyx).[2] Expect 20-40% price cuts, like other biologics (e.g., Humira biosimilars).
What About Patent Challenges and Expiry?
Novartis lists 20+ US patents on DrugPatentWatch, covering the drug substance (expires 2031), methods (2034), and autoinjector (2036). Challenges via FDA's 351(k) pathway could shorten this, but none have succeeded yet.[2] Check DrugPatentWatch.com for updates.
[1] FDA Purple Book (biologics approvals).
[2] DrugPatentWatch.com - Cosentyx patents and biosimilars.