Bio-Thera and Avalon Pharma Sign MENA Deal for BAT2406, Proposed Dupixent Biosimilar
China’s Bio-Thera Solutions and Saudi Arabia-based Avalon Pharma have entered into commercialization and license agreements for BAT2406, a proposed biosimilar to Dupixent® (dupilumab), covering Saudi Arabia and the broader Middle East and North Africa (MENA) region.
The agreement, announced on August 18, marks another expansion of Bio-Thera’s international biosimilar commercialization strategy and strengthens Avalon Pharma’s growing focus on specialty pharmaceuticals and biologics.
According to Bio-Thera’s announcement, the partnership will give Avalon Pharma responsibility for regulatory approvals and commercialization of BAT2406 across the licensed territory, while Bio-Thera will remain responsible for the product’s development, manufacturing and supply. (Bio-Thera Solutions)
Bio-Thera to Develop, Manufacture and Supply BAT2406
Under the terms of the agreement, Bio-Thera Solutions will retain responsibility for BAT2406’s development, manufacturing and supply. Avalon Pharma, the Saudi-based pharmaceutical company, will handle regulatory submissions and commercialization in Saudi Arabia and the wider MENA region. (Bio-Thera Solutions)
The companies did not disclose financial terms, milestone payments or the specific duration of the agreement.
The deal is the latest in a series of partnerships through which Bio-Thera is seeking to commercialize its biosimilar portfolio internationally with regional pharmaceutical partners.
For Avalon, the agreement adds another high-value biologic to its specialty pharmaceutical pipeline as the company expands beyond its traditional consumer-health and pharmaceutical businesses.
Mohamed Maher Al Ghannam, Managing Director and CEO of Avalon Pharma, said the collaboration represents another milestone in the company’s effort to become a regional leader in specialty pharmaceuticals and biologics. He also highlighted Avalon’s ambitions around pharmaceutical localization and future local manufacturing in Saudi Arabia. (Bio-Thera Solutions)
BAT2406 Targets the Same IL-4/IL-13 Pathway as Dupixent
BAT2406 is being developed as a biosimilar to dupilumab, the active ingredient in Sanofi’s Dupixent.
Dupilumab is a fully human IgG4 monoclonal antibody that targets the interleukin-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes. By blocking IL-4Rα, the drug inhibits signaling from both IL-4 and IL-13, two important drivers of Type 2 inflammation. (Bio-Thera Solutions)
Dupixent is an established biologic therapy with multiple approved indications. In the United States, its approved uses include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis and prurigo nodularis, among other indications. (FDA Access Data)
Bio-Thera says BAT2406 is being developed under biosimilar guidelines from regulatory agencies including China’s NMPA, the U.S. FDA and the European Medicines Agency.
The company received approval in China in 2024 to begin clinical development of BAT2406. At the time, Bio-Thera described BAT2406 as its proposed dupilumab biosimilar for conditions including atopic dermatitis, asthma, prurigo nodularis, chronic rhinosinusitis with nasal polyps and eosinophilic esophagitis. (Bio-Thera Solutions)
Growing Opportunity for Biosimilars in MENA
The agreement comes as pharmaceutical companies increasingly seek to expand access to complex biologic medicines through biosimilars in emerging and growth markets.
Dupilumab has become an important therapy for multiple chronic inflammatory diseases because of its ability to target the underlying Type 2 inflammatory pathway rather than simply treating symptoms.
A biosimilar version, if approved by regulators, could potentially broaden access to dupilumab-based treatment by introducing additional competition into the market. However, BAT2406 remains a proposed biosimilar and will require regulatory approval in the applicable markets before it can be commercially launched.
The commercial territory covered by the Bio-Thera-Avalon agreement includes Saudi Arabia and the broader MENA region, making the partnership potentially significant for regional access to the therapy.
Avalon Expands Its Specialty Pharmaceutical Strategy
For Avalon Pharma, BAT2406 adds another biologic asset to a rapidly expanding specialty portfolio.
The Riyadh-headquartered company says its strategy includes specialty pharmaceuticals, branded prescription medicines, dermatology, consumer healthcare, pharmaceutical manufacturing and technology transfer. Its operations span Saudi Arabia and other markets in the region. (Avalon Pharma)
The company has also been expanding its partnerships in biosimilars and specialty medicines. In February 2026, Avalon and Bio-Thera signed a separate agreement covering BAT3306, a proposed pembrolizumab biosimilar, for Saudi Arabia and MENA. Under that agreement, Bio-Thera retained responsibility for development, manufacturing and supply, while Avalon assumed regulatory and commercialization responsibilities. (Bio-Thera Solutions)
The BAT2406 deal therefore builds on an existing commercial relationship between the two companies and further aligns Bio-Thera’s biosimilar pipeline with Avalon’s regional commercialization capabilities.
Bio-Thera Continues International Biosimilar Expansion
Bio-Thera has been building a diversified portfolio of biosimilars and innovative biologics, with several products already approved in major markets.
The Guangzhou-based company currently has biosimilar products targeting several major biologic therapies, including adalimumab, bevacizumab, ustekinumab, golimumab and tocilizumab. Some of its products have received approvals in the United States, European Union and China. (Bio-Thera Solutions)
The company has increasingly relied on partnerships with regional and global pharmaceutical companies to commercialize its products outside China.
For BAT2406, Avalon provides a regional partner with regulatory and commercial capabilities in Saudi Arabia and surrounding MENA markets, while Bio-Thera can focus on development, manufacturing and global supply.
Potential to Improve Access to Biologic Therapies
If approved, BAT2406 could become another option for patients with Type 2 inflammatory diseases across Saudi Arabia and MENA.
The companies emphasized that the partnership is intended to expand access to high-quality biologic medicines for patients with chronic inflammatory conditions.
“This collaboration represents another significant step in Bio-Thera’s mission to develop and deliver high-quality biosimilars that improve access to life-changing therapies for patients in MENA and around the world,” said Bert Thomas, Senior Vice President of Business Development and Alliance Management at Bio-Thera. (Bio-Thera Solutions)
The agreement also fits with Saudi Arabia’s broader efforts to develop domestic pharmaceutical capabilities and attract technology, manufacturing and commercialization partnerships to the Kingdom.
For Bio-Thera, the partnership provides another route into the MENA market for one of its key autoimmune-disease biosimilar programs. For Avalon, BAT2406 strengthens its position in specialty biologics and potentially gives the company another important growth opportunity in the region.
The next major milestones will be regulatory submissions and approvals for BAT2406 in the licensed markets, followed by commercialization. Until those approvals are obtained, BAT2406 remains a proposed biosimilar and is not yet an approved alternative to Dupixent.
References
- Bio-Thera Solutions — Avalon Pharma and Bio-Thera Execute Exclusive Commercialization Agreement for BAT2406
- Bio-Thera Solutions — BAT2406 Receives Clinical Trial Approval in China
- FDA — DUPIXENT (dupilumab) Prescribing Information
- DailyMed — DUPIXENT (dupilumab)
- Avalon Pharma — About Us
- Bio-Thera and Avalon Pharma — BAT3306 Commercialization Agreement
