iBio, a biologics contract manufacturing organization and biotechnology company, announced in a March 26, 2020 press release that it has entered into a second statement of work under its master joint development agreement (MJDA) with AzarGen Biotechnologies, which was signed in 2018. Under the MJDA, initial contract development and manufacturing of AzarGen’s biosimilars will take place at iBio’s Bryan, Texas facility, and ultimately, iBio plans to transfer its proprietary FastPharming manufacturing system to AzarGen in South Africa for production of critical biological medicines for the African continent.
In September 2019, AzarGen contracted with iBio to manufacture research quantities of rituximab for bioanalytical testing. Having successfully completed the initial work, iBio will now manufacture and characterize additional supplies to enable pre-clinical studies comparing plant-made rituximab to the original molecule made using genetically engineered mammalian cells.
The reference biologic for biosimilar rituximab is Roche’s Rituxan (rituximab). According to FDA, Rituxan is approved for B-cell non-Hodgkins lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.