In October 2024, China based Bio-Thera Solutions (Bio-Thera) and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to Johnson & Johnson’s Stelara (ustekinumab).
Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206
Home/Pharma News | Posted 05/11/2024 0 Post your comment
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 [1].
Under the terms of the agreement, Bio-Thera will be responsible for development, manufacturing, and supply of BAT2206, and Richter will have exclusive rights to commercialize the product in the European Union, Switzerland, the UK, and selected other countries.
Bio-Thera filed for regulatory approval of BAT2206 with the European Medicines Agency on 1 July 2024.
In 2021, Bio-Thera entered a licensing and supply agreement with Pharmapark for BAT2206. Under this agreement, Russia’s Pharmapark has exclusive rights to distribute and market the drug, which holds the status of a local product in Russia and other Commonwealth of Independent States countries [2]. This agreement builds on a prior licensing and supply agreement between the two companies to market a golimumab biosimilar [3].
Bio-Thera has also out-licensed this biosimilar to Hikma Pharmaceuticals to commercialize the product in the US [4].
Related articles
FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars
LATIN AMERICAN FORUM View the latest headline article: Los nueve fármacos biológicos más vendidos en 2023 Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO Ver el último artículo de cabecera: Los nueve fármacos biológicos más vendidos en 2023 !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. |
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. Ustekinumab biosimilars: new international biopharma agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/pharma-news/ustekinumab-biosimilars-new-international-biopharma-agreements
3. 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 2024 Nov 5]. Available from: www.gabionline.net/pharma-news/Bio-Thera-partners-with-Pharmapark-to-market-golimumab-biosimilar-in-Russia-and-other-CIS-countries
4. GaBI Online - Generics and Biosimilars Initiative. Licensing agreements signed for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/pharma-news/licensing-agreements-signed-for-ustekinumab-biosimilars
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.
Guidelines
Regulatory update for post-registration of biological products in Brazil
New regulations in Brazil for the registration of biosimilars
Policies & Legislation
NPRA Malaysia trials new timelines for variation applications
Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
Advances for Biocon Biologics’ Stelara and Eylea biosimilars
China’s Hasten Biopharma acquires 14 products from Celltrion
Coherus sells adalimumab biosimilar Yusimry to HKF for US$40 million amid oncology focus
Biocon and Biomm forge alliance to bring semaglutide diabetes treatment to Brazil
Comments (0)
Post your comment