The U.S. Food and Drug Administration has okayed Dei BioPharma Founder Dr. Matthias Magoola’s plan to develop a lower-cost version of a widely used cancer immunotherapy.
In a letter to Dr. Magoola dated July 14, the FDA sent detailed preliminary comments on PSI-033, its proposed biosimilar to Yervoy, a cancer drug sold by Bristol Myers Squibb.
The comments came ahead of a meeting between the company and the agency set for July 22.
Dr. Magoola, a Ugandan scientist and innovator, who through his Dei BioPharma Ltd. is developing a major manufacturing facility that will make biological drugs and vaccines affordable for local, regional and international markets, will lead the meeting with the FDA.
According to information on the record, the development falls under what the FDA calls a biosimilar development Type 2b engagement, a stage meant to give companies targeted advice on specific issues such as analytical strategy, manufacturing controls and study design.
In a statement, Dei BioPharma said the FDA had indicated that several parts of the development program were achievable, including the proposed formulation, the stability-testing plan, the approach to viral-clearance studies and a manufacturing strategy built on three consecutive commercial-scale batches at the 500-liter scale.
The FDA also signaled that an animal study might not be needed if data show high similarity to Yervoy. And it indicated that a separate clinical efficacy study might not be required if analytical work and a pharmacokinetic study show no clinically meaningful differences — a step that could shorten the path to market. The company would have to justify that approach in any future filing, the FDA said.
Because ipilimumab, the active ingredient, carries a risk of serious immune-related side effects, the FDA advised that the pharmacokinetic study not be run in healthy volunteers and that it collects enough safety data to assess those risks in each treatment group.
“The FDA’s detailed preliminary comments give us a clear, product-specific roadmap for strengthening the analytical package, completing the clinical-pharmacology program and preparing PSI-033 for a future U.S. licensing application,” said Dr. Magoola, Dei BioPharma’s founder. “We intend to address these recommendations with urgency and scientific rigor.”
The demand for the cancer treatment is high all over the world. Bristol Myers Squibb reported about $2.9 billion in worldwide Yervoy sales in 2025, up 15% from the year before. The FDA currently lists no approved ipilimumab biosimilar, meaning Dei BioPharma could be among the first to market in the U.S. — and will depend on its own progress, competing applications and the agency’s review.
Dei BioPharma said it is developing additional proposed biosimilars, including a version of Opdivo, another Bristol Myers Squibb cancer drug that brought in about $10 billion in 2025.
“Our engagement with FDA extends beyond PSI-033,” Dr. Magoola said. “This portfolio approach is central to our objective of building globally competitive biologics-development and manufacturing capacity in Uganda and expanding access to important medicines.”
Dr. Magoola added: “Our dream of making biological drugs available and affordable to more than 80% of countries who cannot afford these medicines is coming to fruition.”
Dei BioPharma has indicated that it aims to submit its application for PSI-033 within about nine months, subject to completing the remaining analytical and clinical work and staying aligned with the FDA.
Dei BioPharma Ltd., a Ugandan-based biotech firm, develops biologic medicines, biosimilars and vaccines and it is working to build competitive pharmaceutical research and manufacturing capacity in Africa. Established in 2014 by Dr. Magoola, the company operates a manufacturing complex at Matugga which is one of Africa’s largest.
The flagship plant was inaugurated in July 2021 by President Museveni and Kenyan President William Ruto.
The company campus occupies more than 250 acres and is designed to produce medicines across a broad range of therapeutic areas — including treatments for malaria, HIV and cancer, as well as insulin, monoclonal antibodies and mRNA-based therapeutics. Uganda’s National Drug Authority licensed the company in May 2024 to begin manufacturing medicines, including non-beta-lactam tablets and hard gelatin capsules.
Dei BioPharma holds more than 100 patents filed with the U.S. Patent and Trademark Office and is preparing to produce mRNA vaccines to international standards, and it projects the creation of tens of thousands of jobs.
