Samsung Biologics scores large-scale ublituximab manufacturing deal

TG Therapeutics secures long-term capacity to meet anticipated demand for promising investigational glycoengineered monoclonal antibody

Samsung Biologics says it has expanded its large-scale contract manufacturing deal with TG Therapeutics --first agreed in 2018 -- for the supply of the biotech's investigational anti-CD20 monoclonal antibody, ublituximab.

TG Therapeutics has completed a rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration requesting approval of ublituximab, in combination with UKONIQ (umbralisib), TG Therapeutics’ treatment for patients with chronic lymphocytic leukemia.

Ublituximab was also the subject of two successful Phase III trials in patients with relapsing forms of multiple sclerosis and a BLA is currently being prepared for this indication.

Michael Weiss, Executive Chairman and CEO of TG Therapeutics, explained that the recent positive ULTIMATE I and II MS Phase III studies encouraged the company to consider the potential commercialization of ublituximab across both oncology and autoimmune indications which, in turn, motivated it to re-evaluate its supply needs.

According to Weiss, the company needed to secure long-term capacity to "meet the potential global demand for ublituximab".

Samsung Biologics is currently building its fourth and largest biomanufacturing facility in Incheon, Korea. Upon completion, which is expected in 2023, the contract development and manufacturing company (CDMO) will hold 620,000 L of biomanufacturing capacity, or approximately a quarter of the entire bio-CMO capacity globally.