Celltrion–Rani partnership for RaniPill biosimilars

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Celltrion and Rani Therapeutics (Rani) have entered a partnership under which Celltrion will supply ustekinumab and adalimumab biosimilars for RaniPill products under an exclusive license and supply agreement.

Pills V13D05

In January 2023, it was announced that Celltrion will supply Rani’s ustekinumab biosimilar drug substance, CT-P43, for the oral RT-111 RaniPill programme. Now, in June 2023, a second deal is made that Celltrion will exclusively supply Rani with the adalimumab biosimilar drug substance (CT-P17) required for its RT-105 RaniPill.

In 2021 and 2022, Rani announced the launch and development of new oral, needle-free methods to deliver large biological drug molecules, such as ustekinumab [1] and adalimumab [2]. These are known as RaniPills RT-111 and RT-105, respectively. The RaniPill capsule is designed to administer biologicals with bioavailability comparable to subcutaneous injection.

The recent partnership will see the development and supply of the biosimilars for these pills. Under the terms of the agreement, Celltrion will exclusively supply to Rani the ustekinumab (CT-P43) and adalimumab (CT-P17) biosimilar drug substances required for the RaniPills. Rani is granted an exclusive license to use CT-P43 and CT-P17 in the development and commercialization of RT-111 and RT-105, and Celltrion is granted a right of first negotiation to acquire worldwide rights to RT-111 and RT-105 following a phase I clinical trial.

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1. GaBI Online - Generics and Biosimilars Initiative. Ustekinumab biosimilars: new international biopharma agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 14]. Available from: www.gabionline.net/pharma-news/ustekinumab-biosimilars-new-international-biopharma-agreements
2. GaBI Online - Generics and Biosimilars Initiative. Needle-free delivery of biological drugs from Rani and Progenity (gabionline.net) [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jul 14]. Available from: www.gabionline.net/biosimilars/general/needle-free-delivery-of-biological-drugs-from-rani-and-progenity

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