Celltrion Develops Oral 'Stelara' Biosimilar with US Biotech Partner

Annual Sales of 11 Trillion Blockbuster
Oral Treatment More Convenient Than Intravenous and Subcutaneous Injections

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

[Asia Economy Reporter Chunhee Lee] Celltrion announced on the 9th that it has signed a contract with Rani Therapeutics, a biotech company based in San Jose, USA, to develop an oral 'ustekinumab' drug.

Ustekinumab is originally developed by Janssen (a subsidiary of Johnson & Johnson) under the brand name Stelara. It is a treatment for autoimmune diseases such as psoriasis, arthritis, Crohn's disease, and ulcerative colitis. According to Johnson & Johnson, Stelara generated blockbuster sales of $9.134 billion (approximately 11.4814 trillion KRW) in 2021. The substance patent expires in the US this September and in Europe in July 2024, leading to fierce competition in the biosimilar (biopharmaceutical generic) market. Celltrion disclosed last September that its 'CT-P43' demonstrated equivalent efficacy and similar safety to Stelara in Phase 3 clinical trials.

Through this contract, Celltrion will exclusively supply CT-P43 required for preclinical and Phase 1 clinical trials of oral ustekinumab (development code RT-111) to Rani Therapeutics and will obtain the first negotiation rights for global development and sales in the future.

Rani Therapeutics has developed a platform technology that enables intravenous (IV) and subcutaneous (SC) protein and antibody drugs to be administered orally through its proprietary oral capsule platform, 'RaniPill.' The oral capsule made with RaniPill technology disintegrates in the small intestine, delivering the drug via dissolvable microneedles contained within the capsule to the small intestine and then into the bloodstream. Although it is an oral drug, it is designed to deliver the drug similarly to injections through microneedles embedded inside the capsule.

Janssen (a subsidiary of Johnson & Johnson)'s autoimmune disease treatment 'Stelara' (generic name 'Ustekinumab')

Starting with the collaboration on the development of oral ustekinumab, Celltrion plans to expand cooperation to apply innovative drug delivery platforms across its entire product pipeline, including CT-P43 currently under development. Through this, it is expected that the products under development will also have differentiated competitiveness.

A Celltrion official said, “While developing CT-P43 independently, we are also collaborating on the development of an oral therapeutic, which we expect will secure differentiated product competitiveness for CT-P43,” adding, “We will do our best to secure global competitiveness by leading the way in solving unmet needs and improving patient convenience with differentiated formulations such as the RaniPill capsule.” Talat Imran, CEO of Rani Therapeutics, also stated, “We are pleased to collaborate with Celltrion on RT-111,” and added, “We look forward to future research results and hope to expand the partnership between the two companies.”

This content was produced with the assistance of AI translation services.