Kashiv BioSciences and MS Pharma have announced an exclusive licensing and supply agreement for ADL-018, a biosimilar candidate to Novartis' Xolair (omalizumab), targeting the Middle East and North Africa (MENA) pharmaceutical market. The partnership aims to expand patient access to this monoclonal antibody therapy across a region where Xolair generated approximately $60 million in sales in 2024, according to IQVIA data.
Strategic Partnership Structure
Under the agreement terms, Kashiv BioSciences retains responsibility for product development within the designated territories, while MS Pharma will manage licensing, distribution, and commercialization activities across all MENA countries. The partnership includes an option for local manufacturing at MS Pharma's state-of-the-art biologics facility in Saudi Arabia, potentially enhancing supply chain efficiency and market access.
"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."
Therapeutic Applications and Market Potential
ADL-018 is a proposed biosimilar to Xolair, a humanized monoclonal antibody that targets free immunoglobulin E (IgE). The therapy addresses multiple therapeutic areas including Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU), severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergies.
The global market for the reference product represents significant commercial opportunity, with IQVIA reporting worldwide sales of approximately $4.5 billion in 2024. This substantial market size underscores the potential impact of biosimilar competition in improving treatment accessibility and affordability.
Regulatory Timeline and Market Entry
MS Pharma plans to submit regulatory applications for ADL-018 approval in MENA countries during the fourth quarter of 2025. The company's established regional presence and regulatory expertise position it to navigate the diverse approval processes across multiple MENA jurisdictions.
"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."
Company Capabilities
Kashiv BioSciences operates as a vertically integrated biopharmaceutical company with commercial and advanced clinical-stage assets, distinguishing itself as one of the few U.S.-based companies capable of both manufacturing and receiving marketing authorization for multiple biosimilars. The company's infrastructure spans global R&D, clinical development, manufacturing, regulatory affairs, and intellectual property capabilities through its U.S. operations and Indian subsidiaries.
MS Pharma serves as a leading regional pharmaceutical company in the MENA region, specializing in the development, production, and distribution of generic and biologic therapies. The partnership leverages MS Pharma's regional market knowledge and distribution networks to facilitate ADL-018's market entry across diverse MENA healthcare systems.
