Shilpa Biologicals and SPIMACO Bio sign strategic license agreement for PD-1 Biosimilar for MENA market

Shilpa Biologicals, an integrated biologics development and manufacturing organisation, announces an exclusive Middle East and North Africa (MENA) strategic licensing and commercialization agreement with SPIMACO Bio of Saudi Arabia for  portfolio of PD-1 inhibitor biosimilars across the Middle East and North Africa (MENA).

Under the agreement, Shilpa Biologicals retains ownership of the intellectual property and serves as exclusive developer and manufacturer — earning upfront, development, and commercial milestone payments and product-supply revenue — while SPIMACO Bio leads commercialization, regulatory execution, and market access across the region. The partnership demonstrates Shilpa Biologicals’ integrated biologics development and manufacturing capabilities, reinforcing its position as a global partner for the development, technology transfer and commercial manufacture of complex biologic medicines.

PD-1 inhibitors are among the most important advances in modern oncology — a class of immunotherapy that helps the body’s own immune system recognize and attack cancer cells across a broad range of tumor types. By combining Shilpa Biologicals’ end-to-end development and manufacturing capabilities with SPIMACO Bio’s regional reach, the partnership aims to make these life-changing therapies more accessible and affordable for patients across MENA, where the cancer burden continues to rise.

The collaboration is structured around a phased technology transfer programme that will establish local manufacturing of the biosimilars in Saudi Arabia. This will strengthen regional supply security, build high-value biomanufacturing capability within the Kingdom, and support the localization objectives of Saudi Vision 2030 — reinforcing both companies’ commitment to a resilient and increasingly self-sufficient 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.”

The global PD-1/PD-L1 inhibitor market is valued at approximately US$74 billion in 2026 and is projected to reach US$142 billion by 2031, a compound annual growth rate of about 13.9% (Mordor Intelligence, 2026). Within the Middle East oncology drugs market is estimated at US$3.4 billion and forecast to grow at roughly 7.7% annually through 2031 (Cognitive Market Research, 2025). This opportunity is expected to widen further as leading originator PD-1 therapies approach loss of market exclusivity, accelerating demand for high-quality, more affordable biosimilar alternatives.

“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.