Celltrion and Rani Therapeutics to Jointly Develop Oral Formulation of Ustekinumab Biosimilar

Yesterday, Celltrion and US-based Rani Therapeutics (“Rani”) announced that they will jointly develop an oral formulation of CT-P43, a biosimilar to Stelara® (ustekinumab), indicated for the treatment of psoriasis, Crohn’s disease, and ulcerative colitis. Celltrion’s CT-P43 biosimilar is currently only available in two injectable formulations – intravenous and subcutaneous.

According to its website, Rani Therapeutics has developed “a ’robotic’ pill that incorporates a number of innovations, enabling it to navigate through the stomach and enter the small intestine.” Rani describes how its RaniPill™ capsule is broken down by stomach acids before entering the small intestine and releasing soluble microneedles to inject a protein or antibody drug into the intestinal wall – “where there are no sharp pain receptors, so the injection is painless.” Celltrion will exclusively supply CT-P43 to Rani for the non-clinical and phase 1 clinical trials of an oral formulation of ustekinumab with the potential to expand throughout its product pipeline.