Large molecule-based therapies are delivered by injection because they are not readily absorbed in the GI tract. However, injection methods are more expensive and can lead to low adherence due to the discomfort of injection. Both providers and patients are said to prefer oral delivery methods.

In early 2022, Rani announced the launch of the RaniPill High Capacity (HC). The original RaniPill [1] is a dissolvable robotic pill that navigates through the stomach and into the small intestines, where a microneedle injects medication into the intestinal wall. This method provides a less painful way to take medications that are usually given by injection. The RaniPill is designed to deliver large molecule biological drugs, so it is useful for delivering therapies such as basal insulin, human growth hormones, rheumatoid arthritis and monoclonal antibody immunology medications. The new RaniPill HC can deliver loads of 18 mg whereas its lower dose form could only deliver 3 mg.

The company stated that the higher doses available with the RaniPill HC add over 50 biological drug candidates to its repertoire, including Humira (adalimumab). Humira is a blockbuster biological immunology treatment created by AbbVie. Rani hopes to make a biosimilar of Humira to be delivered via the RaniPill, this will be in addition to other biosimilars in development, such as their capsule of teriparatide, a parathyroid hormone treatment for osteoporosis that has initiated a phase I clinical study.

Progenity’s oral biopharmaceutical delivery system (OBDS) is also being developed and the company is working with its own proprietary liquid formulations of adalimumab and liraglutide (Victoza/Saxenda biosimilar). The company’s preclinical studies have shown promise through the evaluation of delivery of their adalimumab biosimilar directly to the colon in a swine model of induced colitis. Results suggest that targeted topical delivery of adalimumab may be safer and provide an advantage over systemic delivery.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Ustekinumab biosimilars new international biopharma-agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 22]. Available from: www.gabionline.net/pharma-news/ustekinumab-biosimilars-new-international-biopharma-agreements

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