By Fineline Cube Bio-Thera Solutions, Ltd. (SHA: 688177) and Saudi Arabia‑headquartered Avalon Pharma announced the expansion of their partnership, signing a new licensing agreement under which Avalon Pharma will secure exclusive rights to distribute and commercialize BAT2406, a Dupixent (dupilumab) biosimilar, in Saudi Arabia and across the Middle East and North Africa (MENA) region.
Deal Structure
| Item | Detail |
|---|---|
| Deal Type | Exclusive licensing / commercialization agreement |
| Product | BAT2406 (biosimilar candidate referencing Sanofi’s Dupixent / dupilumab) |
| Licensee | Avalon Pharma (Saudi Arabia HQ) |
| Territory | Saudi Arabia + other MENA markets |
| Bio‑Thera’s Role | R&D, manufacturing, and commercial supply of BAT2406 |
| Avalon’s Role | Exclusive commercialization rights across MENA |
| Announcement Date | 19 Aug 2026 |
Product Profile – BAT2406
- Reference Product: Sanofi’s Dupixent (dupilumab)
- Class: Biosimilar candidate targeting type 2 inflammatory and related atopic/allergic diseases
- Indications Under Development:
- Atopic dermatitis
- Asthma
- Prurigo nodularis
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- Division of Responsibilities: Bio‑Thera Solutions handles development, manufacturing and supply; Avalon Pharma executes regional commercialization.
Partnership History – Second MENA Collaboration
| Collaboration | Product | Reference Drug | Territory |
|---|---|---|---|
| First Agreement | BAT3306 | MSD’s Keytruda (pembrolizumab) biosimilar | MENA region |
| New Agreement | BAT2406 | Sanofi’s Dupixent (dupilumab) biosimilar | Saudi Arabia + MENA |
This marks the second collaboration between the two companies, building on the prior BAT3306 (pembrolizumab biosimilar) agreement for the same region and signaling a deepening strategic alliance in biosimilars.
Market Impact & Outlook
- Blockbuster Reference Market: Dupixent is one of the world’s top‑selling immunology drugs, making a dupilumab biosimilar a high‑value asset as exclusivity cliffs approach.
- MENA Growth Opportunity: Saudi Arabia and the broader MENA region represent an expanding biologics market where local commercial partners like Avalon Pharma provide regulatory navigation and market access.
- Pipeline Synergy: With both BAT3306 (Keytruda biosimilar) and BAT2406 (Dupixent biosimilar) in the same regional partnership, the alliance now spans oncology and immunology franchises.
- Watch Items: Regulatory submissions for BAT2406 in MENA markets, development milestones, and potential further expansion of the Bio‑Thera × Avalon partnership to additional assets or territories.
Forward-Looking Statements
This brief contains forward‑looking statements regarding clinical development, regulatory approvals, and commercial expectations for BAT2406. Actual results may differ due to risks including regulatory decisions, manufacturing and supply execution, and competitive dynamics in the MENA region.-Fineline Info & Tech