Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars

Biosimilars/News | Posted 29/10/2021 post-comment0 Post your comment

China’s Bio-Thera Solutions and South Korea’s Samsung Bioepis have begun phase III clinical trials for biosimilars to Janssen’s blockbuster anti-inflammatory drug Stelara (ustekinumab).

Stethoscope MD002364 V13F21

Ustekinumab is a monoclonal antibody that blocks the inflammatory cytokines interleukin (IL) 12 and IL 23. It is indicated for the treatment of several inflammatory conditions including inflammatory bowel disease (IBD), plaque psoriasis and psoriatic arthritis. It is sold under the brand name Stelara by originator firm Janssen Pharmaceuticals and administered intravenously or subcutaneously.

Patents on Stelara are set to expire in September 2023 in the United States and in January 2024 in most parts of Europe, with a number of biosimilars under development [1].

In July 2021, the South Korean firm Samsung Bioepis began a phase III clinical trial for their ustekinumab biosimilar, SB17. The multicentre, randomized and double-blind trial will evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB17 compared to the originator product (Stelara) in patients with moderate to severe plaque psoriasis. The trial will include over 400 patients across eight countries.

Bio-Thera Solutions (Bio-Thera) have also begun a phase III clinical trial for their proposed biosimilar, currently known as BAT2206. The multicentre, randomized, double-blind trial will compare the efficacy and safety of BAT2206 to Stelara in patients with moderate to severe psoriasis. The first patient has now been dosed in the trial, with a further 471 volunteers expected to enrol.

BAT2206 is Bio-Thera's fourth biosimilar to enter a global phase III clinical study, explained Dr Shengfeng Li, Founder and CEO of Bio-Thera, adding: ‘The advancement of BAT2206 into a global Phase III study demonstrates Bio-Thera’s continued commitment to developing biosimilars of important innovative drugs to expand patient access at lower costs’.

Bio-Thera is also developing a number of other biosimilars, including a golimumab biosimilar, phase III trials for which have recently begun [2]. Golimumab (Simponi) is a monoclonal antibody treatment for inflammatory diseases including IBD, rheumatoid arthritis and psoriatic arthritis. Patents on Simponi will expire in 2024 in both the United States and Europe, creating space in the market for competitors.

Bio-Thera’s biosimilar, BAT2506, is the first subcutaneous golimumab biosimilar to enter phase III trials in a number of countries and could be the first to be approved in China and Europe. The trial includes 598 patients with psoriatic arthritis and is expected to complete in October 2023.

Related articles
Positive phase I results for Meiji’s ustekinumab biosimilar

Samsung Bioepis and Eden Biologics announce new biosimilars trials

Biosimilars of ustekinumab

LATIN AMERICAN FORUM

The new section of 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: Los datos apoyan la intercambiabilidad de los biosimilares de la UE

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: Los datos apoyan la intercambiabilidad de los biosimilares de la UE

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. Clinical trials begin for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-ustekinumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 29]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-bio-thera-s-golimumab-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.

comment icon Comments (0)
Post your comment
Related content
FDA approves pegfilgrastim and rituximab biosimilars
18794124_l
Biosimilars/News Posted 24/06/2022
Byooviz: first ophthalmology biosimilar launches in US
VEGF allaboutvision.com V21D02
Biosimilars/News Posted 17/06/2022
Canada approves five biosimilars in last seven months
Health Canada V13I20
Biosimilars/News Posted 03/06/2022
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010