The U.S. Food and Drug Administration (FDA) has accepted an application from Uganda’s Dei BioPharma for the review of its Abbreviated New Drug Application (ANDA) for liraglutide, a multibillion-dollar treatment for diabetes and weight loss, marketed under the brand name Victoza.
The FDA’s decision, officially recorded on April 23, 2025, paves the way for the company’s entry into the lucrative market for GLP-1 receptor agonists, a class of drugs that includes both liraglutide and semaglutide (Ozempic). Industry analysts project that the GLP-1 market could soar from USD 53.46 billion in 2024 to over USD 322.85 billion by 2034.
Dei BioPharma, led by Ugandan scientist and entrepreneur Dr. Matthias Magoola is positioning itself as a global leader in generic versions (Biosimilars) of these drugs.
The company estimates that it could generate revenues of between USD 5–10 billion within the next three years from the marketing of these products alone. Dr. Magoola is the founder and managing director of the biotech firm, which is based in Matugga, just outside Kampala.
In the latest innovation, the GLP-1 agonists as shown in a recent paper by Dr Magoola has changed the arena of multiple therapies, from diabetes to cancer to neurological disorder to most important the first safe drug for weight loss, an issue with most of the developed world.
Dei BioPharma has also developed an oral dosage form in place of the current injection that will further expand the market of these drugs like liraglutide and semaglutide.
Dei BioPharma is the first company in Africa to have completed the development of these drugs and has filed evaluation papers with the US FDA.
Dei BioPharma is focused on being the first company outside of the developed countries to launch this product at an affordable price, a market that can easily grow into hundreds of billions dollars in a short time.
“It is the intent of Dei BioPharma to earn enough foreign exchange to enable Uganda to pay off all of its IMF loans and other obligations,” says Dr. Magoola.
The FDA approval comes amid a string of scientific and regulatory achievements by Dei BioPharma.
Dei BioPharma under Dr. Magoola has been recognized for success and achievements for innovative discoveries in advanced therapies.
Last year, the biotech outfit received a written response to its Pre-Investigational New Drug Application (pre-IND) questions submitted to the U.S. Food and Drug Administration (FDA) regarding the development of its lead asset, RNAT-89 (BLA-761423), an mRNA LNP formulation to express darbepoetin, as the first in class such product presented to the FDA, with the agency giving a preliminary no objection.
This product is used to treat acute kidney failure, cancer, and severe anaemia. Once fully approved, Dei BioPharma is promising affordable Biological drugs, that are currently out of reach and unaffordable to more than 80% of the people around the world.
