Amgen announces positive phase III results for ustekinumab biosimilar

Biosimilares/Investigación | Posted 29/04/2022 post-comment0 Post your comment

Amgen has announced positive results from a phase III trial of its ustekinumab biosimilar, ABP 654. The trial met its primary endpoint, demonstrating no clinically meaningful differences with the originator product, Stelara.

ST002293

Ustekinumab, sold under the brand name Stelara by originator firm Janssen Pharmaceuticals, is a monoclonal antibody indicated for the treatment of a number of inflammatory conditions including inflammatory bowel disease (IBD), plaque psoriasis, and psoriatic arthritis. It works by targeting the inflammatory molecules IL-12 and IL-23.

Amgen is developing a biosimilar version of ustekinumab, currently named ABP 654. On 18 April 2022, the firm announced preliminary results from a phase III trial evaluating the efficacy and safety of ABP 654 compared to Stelara in adults with moderate to severe plaque psoriasis.

The trial met its primary efficacy endpoint, demonstrating no clinically meaningful differences between ABP 654 and Stelara.

The primary analysis evaluated the percentage improvement from baseline to Week 12 of psoriasis area severity index (PASI), which showed a mean difference of percentage improvement between ABP 654 and Stelara of 0.14 (which was within pre-specified margins). The safety profile of ABP 654 was also comparable to Stelara.

David M Reese, MD, Executive VP of R & D at Amgen, commented: ‘Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines. We look forward to continuing to expand our inflammation portfolio to offer patients a variety of treatment options’.

Amgen currently has 11 biosimilars in its portfolio, including five that have been approved by the US Food and Drug Administration and three that are approved in the European Union. The firm recently discussed expectations of a ‘steady flow’ of biosimilar launches, including for ABP 654, as well as biosimilars for Eylea (aflibercept) and Soliris (eculizumab) [1].

Other firms developing ustekinumab biosimilars worldwide include Bio-Thera and Samsung Bioepis [2] and Japan-based Meiji Seika Pharma (Meiji) [3].

Related articles
Ustekinumab biosimilars: new international biopharma agreements

Clinical trials begin for ustekinumab biosimilars

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 last week’s headline article: Nomenclatura de biológicos y biosimilares en Chile

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 la semana pasada: Nomenclatura de biológicos y biosimilares en Chile

!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. Amgen predicts a steady flow of biosimilar launches [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/general/amgen-predicts-a-steady-flow-of-biosimilar-launches
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/news/bio-thera-and-samsung-bioepis-start-clinical-trials-for-ustekinumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Meiji’s ustekinumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/research/positive-phase-i-results-for-meiji-s-ustekinumab-biosimilar

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 © 2022 Pro Pharma Communications International. All Rights Reserved.

Source: Amgen

comment icon Comments (0)
Post your comment
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010