Is Nivolumab Produced Outside the US?
Yes, non-US-based companies produce nivolumab, primarily as biosimilars to Bristol Myers Squibb's (BMS) original Opdivo. These include manufacturers in China, South Korea, India, and Europe, with production often tied to local regulatory approvals and markets. Biosimilars replicate nivolumab's structure and function for cancer immunotherapy.[1]
Which Non-US Companies Make Nivolumab Biosimilars?
- Samsung Bioepis (South Korea): Developed SB8 (approved as Ondovy in the EU in 2024; also licensed to Biocon in India). Manufacturing occurs at their Incheon, South Korea facility.[2]
- Bio-Thera Solutions (China): Produces BAT1706 (BAT1806), China's first approved nivolumab biosimilar in 2023. Produced in Guangzhou, China.[3]
- Mabscale (China): Manufactures MBS301, approved in China in 2024. Facilities in Shanghai.[4]
- Qilu Pharmaceutical (China): Makes QL1706, approved in China in 2024. Produced in Shandong Province.[5]
- Intas Pharmaceuticals (India): Produces a nivolumab biosimilar (Neovi) for the Indian market, manufactured in Ahmedabad.[6]
- Hetero Drugs (India): Offers a biosimilar version, produced at their Hyderabad facilities.[7]
These companies handle upstream production (cell lines, fermentation) and downstream purification outside the US, though some partner with US firms for global distribution.
Where Are These Biosimilars Approved and Sold?
Approvals are mostly regional:
- China: Multiple (BAT1706, MBS301, QL1706) via NMPA, used domestically to cut costs from Opdivo imports.
- EU: SB8 (Ondovy) approved by EMA in 2024; launch pending pricing negotiations.
- India: Neovi and Hetero's version approved by CDSCO for local use.
No widespread US approvals yet, as FDA biosimilar pathway faces patent litigation from BMS.[1]DrugPatentWatch.com
How Do Biosimilars Compare to Original Opdivo?
They match Opdivo's 100% identical amino acid sequence, similar efficacy (e.g., non-inferiority in lung cancer trials for BAT1706), and safety profile. Pricing is 20-50% lower in approving markets, driving access in Asia.[3][8] US entry awaits patent expiry (key patents to 2028-2034).DrugPatentWatch.com
When Could More Enter Global Markets?
China leads with 4+ biosimilars; EU follows in 2025. India focuses on domestic supply. Competitive threats to BMS include patent challenges (e.g., Samsung's US litigation). Full global penetration hinges on data exclusivity ending ~2028.[1]DrugPatentWatch.com
Sources
[1]: EMA Biosimilar Approvals
[2]: Samsung Bioepis SB8 Announcement
[3]: Bio-Thera BAT1706 Approval
[4]: Mabscale MBS301
[5]: Qilu QL1706
[6]: Intas Neovi
[7]: Hetero Nivolumab
[8]: FDA Biosimilar Guidance