- Shilpa Biologicals Private Limited has signed an exclusive strategic licensing and commercialization agreement with Saudi Arabia’s SPIMACO Bio for a portfolio of PD-1 inhibitor biosimilars across the MENA region.
- Shilpa Biologicals will remain the exclusive developer and manufacturer, while the agreement includes a phased technology transfer program to support local biosimilar manufacturing in Saudi Arabia.
Shilpa Biologicals Private Limited has entered into an exclusive strategic licensing and commercialization agreement with Saudi Arabia-based SPIMACO Bio covering a portfolio of PD-1 inhibitor biosimilars for markets across the Middle East and North Africa (MENA). Under the agreement, Shilpa Biologicals will retain intellectual property ownership and serve as the exclusive developer and manufacturer.
Shilpa Biologicals will receive upfront, development and commercial milestone payments, as well as revenue from product supply. SPIMACO Bio will be responsible for commercialization, regulatory execution and market access across the region. The companies said the collaboration combines Shilpa Biologicals’ integrated development and manufacturing capabilities with SPIMACO Bio’s regional reach.
The agreement also includes a phased technology transfer program intended to support local manufacturing of the biosimilars in Saudi Arabia. According to the companies, the initiative is expected to strengthen regional supply security, expand biomanufacturing capacity in the Kingdom and support the localization goals of Saudi Vision 2030.
PD-1 inhibitors are cancer immunotherapies that help the immune system recognize and attack tumor cells across a range of cancer types. The companies said the collaboration aims to improve access to more affordable therapies as cancer rates continue to rise across MENA.
“This agreement demonstrates Shilpa Biologicals’ ability to develop, manufacture, and transfer complex biologics to global partners while creating long-term value through milestone payments and commercial supply. The partnership will allow the companies to bring PD-1 biosimilars to patients across Saudi Arabia and the wider MENA market.”
Madhav Bhutada, Director, Shilpa Biologicals Private Limited. Prof. Ahmed Al-Jedai, Vice Chairman and Managing Director of SPIMACO Bio
