Celltrion to Collaborate with US Biotech on Developing Oral Humira Biosimilar

US Lani Therapeutics and Oral Product Development Agreement
Improvement of Dosing Convenience

Celltrion announced on the 5th that it has signed a contract with Rani Therapeutics, a biotech company based in San Jose, California, USA, to develop an oral form of adalimumab (development code RT-105).

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

With this, Celltrion has entered into an additional collaboration agreement following the new drug development contract for oral ustekinumab (development code RT-111) signed with Rani in early January.

Under this contract, Celltrion will exclusively supply Rani with CT-P17 (active ingredient adalimumab) necessary for the development of oral adalimumab and will have the first negotiation rights for global development and sales based on the results of the Phase 1 clinical trial of oral adalimumab. Rani will conduct clinical trials on its proprietary technology capable of loading high-dose drugs and develop a high-concentration oral form of adalimumab.

Rani possesses a proprietary oral capsule platform technology called RaniPill, which enhances patient convenience by applying protein and antibody drugs, previously deliverable only via intravenous or subcutaneous injection, in an oral form. RaniPill demonstrates bioavailability comparable to that of subcutaneous injection formulations.

Celltrion expects that this collaboration with Rani will help strengthen its competitiveness in the adalimumab market, which is increasingly focused on high-concentration formulations. According to a Celltrion official, once product development is completed, securing patient dosing convenience is expected to impact the adalimumab market, estimated at approximately 28 trillion KRW.

The original drug Humira, on which CT-P17 is based, is a blockbuster autoimmune disease treatment drug that recorded sales of about $21.237 billion (approximately 27.6081 trillion KRW) last year. In particular, in the US market, considered the largest market, it generated sales of about $18.619 billion (approximately 24.2047 trillion KRW), accounting for more than 87% of global sales.

Celltrion has completed the development of the Humira biosimilar CT-P17 and, after obtaining marketing authorization from the European Medicines Agency (EMA) as the world's first high-concentration formulation, recently received approval from the US Food and Drug Administration (FDA).

A Celltrion official said, "Following the Stelara biosimilar (CT-P43), we have started collaboration on oral drug development with CT-P17 as well, making efforts to diversify treatment methods with differentiated formulations. We will do our best to promote product innovation and secure new drug development competitiveness through various open innovations with domestic and international biotech companies."