FDA Provides Path for Ugandan Firm's Cancer Drug Biosimilar

Dei BioPharma, a Ugandan biotechnology company, has received significant preliminary support from the U.S. Food and Drug Administration (FDA) for its plan to develop a biosimilar to Yervoy (ipilimumab), a prominent cancer immunotherapy.

In a letter dated July 14, the FDA offered detailed comments on PSI-033, Dei BioPharma’s proposed biosimilar. The feedback, part of the FDA’s Biosimilar Development (BPD) Type 2b program, focuses on the drug’s formulation, manufacturing, and clinical study design.

The FDA indicated that crucial aspects of the development program, including the proposed drug formulation and stability-testing plan, are achievable. The agency also noted that animal studies might not be necessary if analytical data strongly demonstrate similarity to the reference product, Yervoy. Furthermore, a separate clinical efficacy study could potentially be waived under similar analytical and pharmacokinetic conditions.

This guidance could substantially shorten the development timeline for PSI-033. However, the FDA advised specific safety protocols for pharmacokinetic studies, recommending they be conducted in patients rather than healthy volunteers to thoroughly assess potential immune-related adverse effects associated with ipilimumab.

Dr. Matthias Magoola, founder and CEO of Dei BioPharma, expressed optimism, stating that the FDA’s comments provide a clear roadmap for the biosimilar’s development and future U.S. licensing application. The company aims to submit its application within approximately nine months, pending the completion of remaining studies and regulatory alignment.

Dei BioPharma is also developing a biosimilar for another Bristol Myers Squibb immunotherapy, Opdivo (nivolumab). The company’s ambition is to establish Uganda as a hub for globally competitive biologic medicine development and manufacturing, thereby increasing access to affordable treatments across Africa and beyond.

Source: Nile Post