Celltrion to develop Humira biosimilar oral medication with US firm

South Korea's biopharmaceutical company Celltrion Inc. announced on Monday that it has signed a contract with the US biotech firm Rani Therapeutics for the development of an oral formulation of adalimumab (CT-P17).

Following their collaboration agreement for the development of an oral formulation of ustekinumab (RT-111) in January this year, the two companies have further extended their partnership. 

Under this new agreement, Celltrion will supply Rani with CT-P17, which is required for the development of the oral formulation of adalimumab.

Based on the results of phase 1 clinical trials for the oral formulation, Celltrion will have priority negotiation rights for global development and sales of the oral adalimumab. Rani will be responsible for developing the high-concentration oral formulation of adalimumab.

Rani possesses the RaniPil technology, which enables the conversion of protein and antibody drugs that were previously administered via intravenous or subcutaneous injections into oral formulations. RaniPill has shown a similar level of bioavailability to subcutaneous injection formulations.

Both companies believe that this collaboration will enhance their competitiveness in the high-concentration formulation-focused adalimumab market.

The original medicine for CT-P17, Humira, is a treatment for autoimmune diseases and generated sales of $21.24 billion last year, with over 87% ($18.62 billion) of the sales coming from the United States.

Celltrion has developed the Humira biosimilar CT-P17 and obtained marketing authorization as the first high-concentration formulation from the European Medicines Agency (EMA). Recently, it also received product approval from the US Food and Drug Administration (FDA).

Write to Min Su Han at hms@hankyung.com