Current Status of Yervoy Biosimilars
No Yervoy (ipilimumab) biosimilars are approved anywhere in the world as of late 2024. Bristol Myers Squibb holds the reference product, approved in 2011 for melanoma and later expanded to other cancers. Development is underway but faces hurdles from multiple patents, including process and formulation claims expiring between 2025 and 2038.[1]
Key Developers and Timelines
Several companies are advancing ipilimumab biosimilars in clinical trials:
- Samsung Bioepis/Horgana (with Organon): Their candidate is in Phase 3 trials (NCT05678446), comparing it to Yervoy in melanoma patients. Topline data expected in 2025; U.S. filing could follow if successful.[2]
- Formycon/Bioeq: FOBI01 completed Phase 1/3 equivalence study in 2024, showing PK/PD similarity to Yervoy. Plans European approval push for 2026.[3]
- Intas Pharmaceuticals: Launched a biosimilar in India (Ipimune) in 2023 after local trials, but it's not approved in regulated markets like U.S. or EU.[4]
- Others in earlier stages: Alvotech (AVT33, Phase 1), Chong Kun Dang (CKD-210, preclinical), and Biocad (planning trials).[1][5]
Most target U.S./EU entry post-2028, pending patent resolutions.
Patent Landscape and Barriers
Yervoy's main composition patent expired in 2024, but Bristol Myers Squibb enforces secondary patents on manufacturing and devices through 2037. This triggered Paragraph IV challenges:
- Samsung Bioepis filed an FDA abbreviated BLA in 2024, likely sparking litigation.[6]
- Formycon anticipates court battles similar to those delaying Humira biosimilars.[3]
Check DrugPatentWatch.com for expiration details and litigation updates: DrugPatentWatch - Ipilimumab Patents.[1]
Market Implications and Comparisons
If approved, these could cut Yervoy's $2B+ annual U.S. sales by 40-60%, like Keytruda's looming biosimilars. They match Yervoy's CTLA-4 mechanism for immunotherapy combos, but pricing may start 20-30% below originator. No direct competitors yet; Opdivo biosimilars (nivolumab) are further along.[7]
Sources
[1]: DrugPatentWatch.com - Yervoy Patents
[2]: ClinicalTrials.gov - Samsung Bioepis
[3]: Formycon Press Release
[4]: Intas Launch Announcement
[5]: GaBI Online Pipeline Tracker
[6]: FDA Purple Book
[7]: Evaluate Pharma Market Forecast