FDA opens door for Uganda’s cancer drug

What the report says

The Observer reports that Ugandan scientist Matthias Magoola and his company, Dei BioPharma, have received preliminary feedback from the U.S. Food and Drug Administration on PSI-033, a proposed lower-cost biosimilar version of the cancer immunotherapy Yervoy. The FDA’s written comments, sent ahead of a July 22 meeting with the company, set out the evidence, studies and manufacturing requirements Dei BioPharma would need to address before seeking U.S. marketing approval.

The development is an early regulatory step, not an approval. According to the report, PSI-033 is intended to be highly similar to Yervoy, whose active ingredient ipilimumab helps the immune system target cancer cells. Because biologic medicines are produced using living cells, regulators require detailed comparisons to confirm there are no meaningful differences in safety, purity or effectiveness from the original product.

The Observer says the FDA indicated parts of Dei BioPharma’s proposed programme may be workable, including formulation, stability testing, viral clearance studies and plans to show consistent commercial-scale manufacturing. The regulator also suggested that animal testing and a separate clinical efficacy study might be unnecessary if laboratory and pharmacokinetic evidence is strong enough, though the company would still need to justify that approach. Because ipilimumab can cause serious immune-related side effects, the FDA advised against testing in healthy volunteers and asked for adequate safety data.

The potential market is significant: The Observer reports Bristol Myers Squibb’s Yervoy sales at about $2.9 billion in 2025, while Dei BioPharma says no ipilimumab biosimilar is currently listed by the FDA. The company says it hopes to file an application for PSI-033 in about nine months if remaining work is completed and regulatory alignment continues.