FDA gives green light to Dei BioPharma’s cancer drug roadmap

What the report says

Watchdog Uganda reports that the U.S. Food and Drug Administration has provided preliminary feedback to Dei BioPharma founder Dr. Matthias Magoola on the Ugandan company’s plan to develop PSI-033, a proposed biosimilar version of Yervoy, the Bristol Myers Squibb cancer immunotherapy whose active ingredient is ipilimumab. The FDA letter, dated July 14, came before a scheduled July 22 meeting between the agency and the company.

According to the report, the engagement is part of an FDA biosimilar development Type 2b process, where companies can receive focused advice on areas such as analytical comparisons, manufacturing controls and study design. Dei BioPharma said the FDA viewed several elements of its plan as feasible, including formulation, stability testing, viral-clearance studies and a manufacturing strategy using three commercial-scale batches at 500 liters. The agency also indicated that animal testing and a separate clinical efficacy study may not be necessary if the company can prove high similarity and no clinically meaningful differences through analytical and pharmacokinetic data.

The article notes that the FDA advised against testing the pharmacokinetic study in healthy volunteers because ipilimumab can cause serious immune-related side effects, and said future submissions would need adequate safety data. This is an important distinction: the reported FDA comments are guidance on the development pathway, not approval of PSI-033 for sale.

Watchdog Uganda reports that Dei BioPharma aims to submit an application for PSI-033 within about nine months, depending on remaining work and regulatory alignment. The company is also pursuing other biosimilars, including a version of Opdivo, as part of its stated goal of building biologics manufacturing capacity in Uganda and improving access to costly medicines.