China-based Bio-Thera Solutions (Bio-Thera) have begun a phase III clinical trial for BAT2506, copy biological of the anti-inflammatory molecule Simponi (golimumab).
Golimumab is a monoclonal antibody that targets the inflammatory molecule tumour necrosis factor-alpha (TNF-alpha). It can be used in the treatment of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and is sold under the brand name Simponi by originator company Janssen.
BAT2506 is a proposed biosimilar to Janssen’s Simponi (golimumab), which is currently approved as a treatment for adults with moderate to severe rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis (PsA) .
In June 2021, China’s Bio-Thera announced the start of a phase III clinical trial for its copy biological of Simponi, currently known as BAT2506. The randomized, double-blind study will compare the efficacy of BAT2506 to originator golimumab in an estimated 480 people with psoriatic arthritis.
Shengfeng Li, CEO of Bio-Thera, said, ‘Patient enrolment in our Phase III clinical trial for BAT2506 is another important achievement for Bio-Thera as it is our third proposed biosimilar to enter a global Phase 3 study’.
Bio-Thera is developing biosimilars for tocilizumab , which is also used to treat inflammatory conditions, and bevacizumab , which is used to treat various forms of cancer. Both have completed phase III trials.
The BAT2506 trial will be performed in China and Europe and is expected to complete in October 2023. Simponi’s patents expire in the US and the EU in 2024.
BAT2506 is the first subcutaneous golimumab copy biological to enter phase III trials in a number of countries and, according to analysis from GlobalData, could be the first golimumab copy biological to be approved in China and Europe. Its only major competition comes from Reliance Life Sciences, which is conducting a phase III trial in India. ‘BAT2506 is the only golimumab biosimilar to initiate a Phase III trial in multiple countries and is expected to reap the maximum benefits of early entrant market penetration’, says Prashant Khadayate, Pharma Analyst at GlobalData.
On 18 July 2020, Bio-Thera has signed a licensing agreement for its proposed golimumab copy biological BAT2506 with Russian biopharmaceutical company Pharmapark, with exclusive rights to distribute and market BAT2506 with the status of a local product in Russia as well as other Commonwealth of Independent States (CIS) countries .
Bio-Thera launches first adalimumab copy biological in China
Positive results for Bio-Thera’s arthritis copy biologicals
LATIN AMERICAN FORUM
The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View this week’s headline article: Solicitudes de biosimilares bajo evaluación de la EMA - julio de 2021
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.
LATIN AMERICAN FORUM
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
Vea el artículo principal de esta semana: Solicitudes de biosimilares bajo evaluación de la EMA - julio de 2021
Explore las noticias en el Foro Latinoamericano!
Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
1. 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 Jul 30]. Available from: www.gabionline.net/pharma-news/Bio-Thera-partners-with-Pharmapark-to-market-golimumab-biosimilar-in-Russia-and-other-CIS-countries
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for tocilizumab biosimilar BAT1806 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/research/positive-phase-iii-results-for-tocilizumab-biosimilar-bat1806
3. GaBI Online - Generics and Biosimilars Initiative. Positive results for Bio-Thera’s bevacizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/research/Positive-results-for-Bio-Thera-s-bevacizumab-copy-biological
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 © 2021 Pro Pharma Communications International. All Rights Reserved.