Kashiv BioSciences and MS Pharma Forge Strategic Alliance to Bring XOLAIR® Biosimilar ADL-018 to MENA Region
Kashiv BioSciences, LLC, a U.S.-based biopharmaceutical company specializing in complex generics and biosimilars, and MS Pharma, a leading pharmaceutical company in the Middle East and North Africa (MENA), announced today the signing of a regional license and supply agreement for ADL-018. This biosimilar candidate to XOLAIR® (omalizumab) will be developed and commercialized specifically for the MENA region. The agreement represents a significant step in both companies’ efforts to increase patient access to biologic therapies that address severe allergic asthma and chronic idiopathic urticaria.
According to IQVIA, global sales of XOLAIR, the reference product to ADL-018, reached approximately $4.5 billion in 2024, with around $60 million generated in the MENA region alone. This underscores both the global and regional demand for omalizumab-based therapies, making the MENA market an important target for biosimilar expansion.
Collaborative Roles in Development and Commercialization
Per the terms of the agreement, Kashiv BioSciences will retain responsibility for the development of ADL-018 across the designated territories. This includes advancing the biosimilar through clinical, regulatory, and technical stages to ensure its comparability, safety, and efficacy to the reference product, XOLAIR.
MS Pharma, in turn, will take on a pivotal role in the licensing, registration, distribution, and commercialization of ADL-018 in the MENA region. The company is also positioned to potentially conduct local manufacturing at its cutting-edge biologics facility in Saudi Arabia, a move aimed at bolstering regional self-sufficiency and enhancing supply chain resilience.
The agreement further deepens the strategic relationship between the two companies and reflects a broader, global trend toward regionalization of biologic manufacturing and commercialization. This strategy not only facilitates faster access to life-saving therapies but also supports local economic development and regulatory alignment.
Executive Commentary: A Shared Vision for Expanding Access
Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences, emphasized the global significance of this agreement, stating:
“This agreement strengthens our partnership with MS Pharma and reinforces our commitment to expanding access to ADL-018 for patients worldwide. This is a key milestone in achieving our goal of growing Kashiv’s biosimilar pipeline and collaborating with global regulatory authorities.”
For Kashiv, which has established itself as a frontrunner in the U.S. biosimilar landscape, the collaboration serves as a launchpad for geographic expansion beyond North America. By leveraging MS Pharma’s regulatory expertise, regional presence, and commercial infrastructure, Kashiv is well-positioned to scale access to biosimilars in underserved markets.
Kalle Känd, Chief Executive Officer of MS Pharma, echoed Dr. Athalye’s sentiments while highlighting MS Pharma’s vision to reshape the pharmaceutical ecosystem across the region:
“We are proud of our partnership with Kashiv Biosciences, which marks a meaningful step in advancing MS Pharma’s vision to transform the bio-pharmaceutical market and expand our footprint across the MENA region. Licensing ADL-018 reinforces our commitment to broadening access to innovative biologic therapies that address critical medical needs.”
He added that MS Pharma’s regionally grounded yet globally scalable approach is key to delivering sustainable, high-quality therapeutics that improve health outcomes and strengthen specialty care infrastructure across the MENA countries.
Regulatory Pathway and Future Milestones
MS Pharma is planning to file for regulatory approval for ADL-018 across key MENA countries in the fourth quarter of 2025. This timeline reflects the growing regulatory maturity of MENA health authorities, which are increasingly aligning their biosimilar review frameworks with those of the FDA, EMA, and WHO.
The regulatory strategy will likely be anchored by robust analytical comparability data, clinical evidence, and global standards for biosimilar development. If approved, ADL-018 could be one of the first biosimilar versions of XOLAIR to be made widely available across the region, providing a more cost-effective treatment option for patients with severe allergic conditions.
In parallel, MS Pharma’s biologics manufacturing plant in Saudi Arabia may play a critical role in producing the biosimilar for regional supply. The facility is part of a broader Saudi Arabian initiative to become a regional hub for pharmaceutical manufacturing, biotechnology innovation, and healthcare investment.
Addressing Unmet Needs in Allergy and Immunology
XOLAIR (omalizumab), a monoclonal antibody that targets immunoglobulin E (IgE), has been widely used for treating moderate to severe persistent asthma in patients with elevated IgE levels and allergic sensitization. It is also indicated for chronic spontaneous urticaria in patients who remain symptomatic despite antihistamine therapy. However, due to its high cost, access to omalizumab remains limited in many low- and middle-income countries, including parts of the MENA region.
A biosimilar such as ADL-018 has the potential to significantly reduce treatment costs, increase competition, and improve patient access. As biologics continue to dominate the treatment landscape for a wide range of immunologic and inflammatory diseases, biosimilars are expected to play an increasingly vital role in ensuring affordability and sustainability within national healthcare systems.
For Kashiv BioSciences, the agreement aligns with its long-term vision to become a global biosimilar player. In addition to ADL-018, the company is actively advancing a portfolio of biosimilar candidates and complex injectables that target high-impact therapeutic areas. Its development capabilities span from cell line development to regulatory submissions, and it operates GMP-certified facilities in both the U.S. and India.
MS Pharma, with its strong regional presence and expanding biologics portfolio, continues to solidify its position as a partner of choice for global biopharmaceutical companies seeking entry into the MENA market. The company’s vertically integrated infrastructure, from development to distribution, gives it the agility needed to meet complex regulatory and supply chain demands across diverse national health systems
The license and supply agreement for ADL-018 between Kashiv BioSciences and MS Pharma represents a landmark collaboration aimed at delivering a high-value biosimilar to one of the most underserved regions in the world. With development responsibility in Kashiv’s experienced hands and regional commercialization led by MS Pharma, the partnership is poised to address critical gaps in access to biologic therapies for allergic and immunologic diseases. Regulatory filings are anticipated by the end of 2025, setting the stage for a potential launch that could reshape the allergy treatment landscape across the MENA region.
As biosimilars gain momentum globally, partnerships like this serve as a blueprint for how innovation, regional expertise, and patient-centered strategies can converge to deliver impactful, affordable healthcare solutions.
