Shilpa Biologicals Private Limited has entered into an exclusive strategic licensing and commercialization agreement with Saudi Arabia’s SPIMACO Bio to bring a portfolio of PD-1 inhibitor biosimilars to 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. The company will receive upfront, development and commercial milestone payments, along with product-supply revenue. SPIMACO Bio will lead commercialization, regulatory execution and market access across the region.

PD-1 inhibitors are cancer immunotherapies that help the immune system recognize and attack tumor cells across a range of cancer types. The partnership combines Shilpa Biologicals’ integrated development and manufacturing capabilities with SPIMACO Bio’s regional reach, with the goal of improving access to more affordable therapies as cancer rates continue to rise across MENA.

The collaboration also includes a phased technology transfer program to support local manufacturing of the biosimilars in Saudi Arabia. The initiative is expected to strengthen regional supply security, expand high-value biomanufacturing capacity in the Kingdom and support the localization goals of Saudi Vision 2030, while reinforcing both companies’ commitment to a more resilient regional healthcare ecosystem.

“This partnership creates significant long-term value for Shilpa Biologicals while advancing our mission to make world-class biologic medicines accessible to patients wherever they live,” said Madhav Bhutada, Director, Shilpa Biologicals Private Limited. “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 – and through a future technology transfer we will also help build durable local manufacturing capability for the region.”

“Expanding access to advanced cancer immunotherapies is a strategic priority for the health and resilience of our region,” said Prof. Ahmed Al-Jedai , Vice Chairman and Managing Director of  SPIMACO Bio. “Partnering with Shilpa Biologicals allows us to bring high-quality, affordable PD-1 biosimilars to patients across Saudi Arabia and the wider MENA market. Shilpa’s scientific depth and scalable GMP manufacturing capabilities make them an ideal partner.