Kashiv BioSciences and MS Pharma have entered into an exclusive licensing and supply agreement for the commercialization of ADL-018, Kashiv’s biosimilar candidate to XOLAIR (bOmalizumab) in the Middle East and North Africa (MENA) region.

XOLAIR is a registered trademark of Genentech, Inc. and Novartis AG. It is indicated for the treatment of Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU), severe allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy.

According to IQVIA, global sales of XOLAIR reached approximately USD 4.5 billion in 2024, with USD 60 million generated in the MENA market.

Under the terms of the agreement, Kashiv BioSciences will lead product development within the agreed territories, while MS Pharma will take on licensing, distribution, and commercialisation responsibilities across MENA. The agreement also includes an option for local manufacturing 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, CEO of Kashiv BioSciences.

“This is a key milestone in achieving our goal of growing Kashiv’s biosimilar pipeline and collaborating with global regulatory authorities,” he added.

Kalle Känd, CEO of MS Pharma, described the partnership as a meaningful step in advancing the company’s vision to transform the bio-pharmaceutical market and expand its footprint across the MENA region.

“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,” he added.

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

Kashiv BioSciences, LLC is a vertically integrated US-based biopharmaceutical company with a robust portfolio of commercial and advanced clinical-stage assets. It is among the few US companies to both manufacture and receive marketing authorisation for multiple biosimilars. The company operates through facilities in the U.S. and India, supporting global R and D, clinical development, manufacturing, regulatory, and IP functions.

MS Pharma, headquartered in Amman, Jordan, is a leading regional pharmaceutical company in the MENA region, specialising in the development, production, and distribution of a broad portfolio of generic and biologic therapies.

The company operates five manufacturing facilities across Jordan, Algeria, and Saudi Arabia, all serving the broader MENA market. With management offices in Zug, Switzerland, MS Pharma operates across 12 countries.