September and October 2021 saw new international agreements between biopharmaceutical companies regarding ustekinumab biosimilars. These were formed between BioFactura and Rani Therapeutics in the US, and China’s Bio-Thera Solutions and Pharmapark in Russia.
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis, and the originator is Janssen’s Stelara [1].
Bio-Thera–Pharmapark agreement
China-based biopharmaceutical company Bio-Thera has reached licensing and supply agreements with Russia-based Pharmapark for their ustekinumab biosimilar (BAT2206). Here, Pharmapark will have exclusive rights to distribute and market the drug, with a status of a local product in Russia and other Commonwealth of Independent States (CIS) countries. This agreement was initiated around a previous licensing and supply agreement between the two companies to market a golimumab biosimilar [2].
Bio-Thera’s ustekinumab biosimilar has completed a phase I study and is now being evaluated in a global phase III clinical study that includes patients from China, Russia and other countries. In due course, Bio-Thera hopes to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Pharmapark will file the dossier in Russia and other CIS countries.
Under the terms of the partnership, Bio-Thera will be responsible for full development, and commercial supply of the biosimilar in Guangzhou, China. Pharmapark will take over sales and marketing in Russia and other CIS countries.
BioFactura–Rani agreement
Under the BioFactura–Rani agreement, Rani will assess BioFactura’s ustekinumab biosimilar (BFI-751) that is made by BioFactura Australia using their StableFast technology, a new platform that allows for the faster generation of fingerprint-like copies of the targeted reference drug. Rani will evaluate BFI-751 in its RaniPill capsule, a new, proprietary and patented platform technology, designed to be a pain-free way to replace the molecules being delivered by injection. This follows the company’s May 2021 announcement that the BFI-751 biosimilar is undergoing phase I clinical trials [3].
Together, Dr Darryl Sampey, BioFactura’s President and CEO, and Dr Jeffrey Hausfeld, Chief Medical Officer and Chairman of the BioFactura Board of Directors noted that, in bringing together BFI-751 with the innovative oral delivery platform, the companies can provide patients with high quality products, and offer improved value and accessibility through their easy-to-swallow treatment option.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera partners with Pharmapark to market golimumab biosimilar in Russia and other CIS countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/pharma-news/Bio-Thera-partners-with-Pharmapark-to-market-golimumab-biosimilar-in-Russia-and-other-CIS-countries
3. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-ustekinumab-biosimilars
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