Kashiv BioSciences and MS Pharma Enter into MENA License and Supply Agreement for ADL-018, Biosimilar Candidate to XOLAIR® (bOmalizumab)

By: Kashiv BioSciences, LLC via Business Wire

August 05, 2025 at 09:00 AM EDT

Kashiv BioSciences, LLC and MS Pharma today announced that the companies have entered into a license and supply agreement for ADL-018, Kashiv BioSciences’ biosimilar candidate to XOLAIR® (bOmalizumab) in the Middle East and North Africa (MENA) region. IQVIA reported global sales of ~$4.5 billion and ~$60 million in MENA in 2024.

Under the terms of the agreement, Kashiv BioSciences is responsible for the development of the product within the agreed territories. MS Pharma will be responsible for the licensing, distribution, and commercialization of ADL-018 in the MENA region, with the option of local manufacturing to be carried out at MS Pharma’s state-of-the-art biologics facility in Saudi Arabia.

“This agreement strengthens our partnership with MS Pharma and reinforces our commitment to expanding access to ADL-018 for patients worldwide,” said Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences, “This is a key milestone in achieving our goal of growing Kashiv’s biosimilar pipeline and collaborating with global regulatory authorities.”

“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,” said Kalle Känd, CEO of MS Pharma. “Licensing ADL-018 reinforces our commitment to broadening access to innovative biologic therapies that address critical medical needs. Through regionally rooted, scalable solutions, we continue to strengthen our specialty and biologics portfolio—driving impact in specialty care and improving health outcomes for the communities we serve.”

MS Pharma plans to submit for regulatory approval in MENA countries in the fourth quarter of 2025.

About ADL-018:

ADL-018 is a proposed Xolair® biosimilar. Omalizumab is a humanized monoclonal antibody that targets free immunoglobulinE (IgE). Xolair® is indicated for the treatment of Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU), severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy. ADL-018 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

Xolair® is a registered trademark of Genentech, Inc. and Novartis AG.

About Kashiv BioSciences:

Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with a robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

About MS Pharma

MS Pharma is a leading regional pharmaceutical company in the MENA region, specializing in the development, production, and distribution of a broad portfolio of generic and biologic therapies. Positioned for rapid growth, the company operates five manufacturing facilities across Jordan, Algeria, and Saudi Arabia — home to a newly launched biologics plant, all serving the broader MENA market. Headquartered in Amman, Jordan, with management offices in Zug, Switzerland, MS Pharma employs over 2,000 people across 12 countries.