Shilpa Biologicals Private Limited, an integrated biologic development and manufacturing organisation, signed an exclusive strategic licensing and commercialisation agreement with Saudi Arabia-based SPIMACO Bio for a portfolio of PD-1 inhibitor biosimilars across the Middle East and North Africa (MENA) region. The agreement combines Shilpa Biologicals’ biologics development and manufacturing capabilities with SPIMACO Bio’s regional commercial, regulatory and market-access expertise. As a result, the partnership aims to expand access to high-quality and affordable cancer immunotherapies across MENA.
Shilpa Biologicals to Develop and Manufacture Biosimilars
Shilpa Biologicals will retain ownership of the intellectual property and serve as the exclusive developer and manufacturer of the PD-1 biosimilar portfolio. The company will receive upfront payments, development and commercial milestone payments, as well as revenue from product supplies. Meanwhile, SPIMACO Bio will lead commercialisation, regulatory execution and market access across the MENA region. This arrangement also highlights Shilpa Biologicals’ integrated capabilities in developing, manufacturing and transferring complex biologic medicines for international markets.
PD-1 Biosimilars to Expand Cancer Treatment Access
PD-1 inhibitors have become an important class of cancer immunotherapy. These medicines help the body’s immune system recognise and attack cancer cells and are used across a broad range of tumour types. Therefore, the collaboration seeks to improve access to these advanced therapies in MENA, where demand for effective and affordable oncology treatments continues to grow. By combining Shilpa Biologicals’ end-to-end development and manufacturing capabilities with SPIMACO Bio’s regional reach, the companies intend to support wider availability of PD-1 biosimilars across the region.
Technology Transfer to Enable Local Manufacturing in Saudi Arabia
In addition, the agreement includes a phased technology transfer programme designed to establish local manufacturing of the biosimilars in Saudi Arabia. The initiative is expected to strengthen regional supply security while developing high-value biomanufacturing capabilities within the Kingdom. It also supports the localisation objectives of Saudi Vision 2030. Through this technology transfer, both companies aim to contribute to a more resilient and increasingly self-sufficient healthcare manufacturing ecosystem in the MENA region.
Strong Growth Potential for PD-1 Biosimilars
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, representing a compound annual growth rate (CAGR) of about 13.9%, according to Mordor Intelligence. Meanwhile, the Middle East oncology drugs market is estimated at US$3.4 billion and is forecast to grow at approximately 7.7% annually through 2031, according to Cognitive Market Research. The opportunity for biosimilars could increase as leading originator PD-1 therapies approach the loss of market exclusivity. This could accelerate demand for high-quality and more affordable alternatives.
Shilpa Biologicals Highlights Long-Term Partnership
“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. He added that the agreement demonstrates Shilpa Biologicals’ ability to develop, manufacture and transfer complex biologics to global partners. The company will also create long-term value through milestone payments and commercial supply, while the future technology transfer will support the development of local manufacturing capabilities in the region.
SPIMACO Bio Focuses on Regional Oncology Access
“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, 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,” he added. As per the press release, the strategic agreement therefore establishes a framework for the development, commercialisation and eventual local manufacturing of PD-1 biosimilars, while supporting broader access to oncology therapies across the MENA region.
