Shilpa Biologicals, a Dharwad, India-based biologics contract development and manufacturing organization (CDMO), has signed an exclusive licensing and commercialization agreement with Saudi Arabia-based SPIMACO Bio for a portfolio of PD-1 inhibitor biosimilars in the Middle East and North Africa region.

Under the agreement, Shilpa Biologicals will retain the intellectual property and serve as the exclusive development and manufacturing partner. SPIMACO Bio will lead regulatory activities, commercialization, and market access across the region, according to the announcement.

The collaboration includes a phased technology transfer program to establish local manufacturing of biosimilars in Saudi Arabia. Shilpa Biologicals will transfer the manufacturing processes and provide development and technology-transfer support as SPIMACO Bio establishes regional production capabilities.

The companies said the agreement is intended to expand access to PD-1 inhibitor biosimilars while building local biopharmaceutical manufacturing capacity in Saudi Arabia. PD-1 inhibitors are used as immunotherapies across multiple cancer types.

The agreement expands Shilpa Biologicals’ involvement in manufacturing complex biologics and follows the company’s commissioning of an antibody-drug conjugate (ADC) drug substance manufacturing facility in Dharwad in June. The facility supports payload and linker synthesis, monoclonal antibody production, conjugation and purification, with GMP qualification activities underway at the time of the announcement.