By: IPP Bureau
Last updated : September 16, 2026 8:05 am
Shilpa Biologicals to retain IP and manufacturing rights, while Saudi Arabia’s SPIMACO Bio will lead commercialization, regulatory execution and market access across the region
Shilpa Biologicals Private Limited, an integrated biologics development and manufacturing organisation, has entered into an exclusive Middle East and North Africa (MENA) strategic licensing and commercialization agreement with Saudi Arabia-based SPIMACO Bio for a portfolio of PD-1 inhibitor biosimilars.
Under the agreement, Shilpa Biologicals will retain ownership of the intellectual property and serve as the exclusive developer and manufacturer. The company will receive upfront, development and commercial milestone payments, in addition to product-supply revenue. SPIMACO Bio will be responsible for commercialization, regulatory execution and market access across the region.
The partnership combines Shilpa Biologicals’ end-to-end biologics development and manufacturing capabilities with SPIMACO Bio’s regional commercial and regulatory reach. The companies aim to expand access to more affordable PD-1 inhibitor therapies across MENA, where the cancer burden is increasing.
The agreement includes a phased technology transfer programme to establish local manufacturing of the biosimilars in Saudi Arabia. The initiative is expected to strengthen regional supply security, develop high-value biomanufacturing capabilities in the Kingdom and support the localization objectives of Saudi Vision 2030.
“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, according to Mordor Intelligence. The Middle East oncology drugs market is estimated at US$3.4 billion and is forecast to grow at around 7.7% annually through 2031, according to Cognitive Market Research.
“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.”