Home / Biosimilars / News / Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA

Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA Posted 27/01/2017

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 18 January 2017 that its candidate adalimumab biosimilar (BI 695501) had been accepted for regulatory review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The product is a proposed biosimilar to AbbVie’s Humira (adalimumab), which had worldwide sales of US$14 billion in 2015. The patents on Humira will expire in the US in November 2017 and in Europe in June 2017 [1].

Boehringer Ingelheim created a dedicated division for the development and commercialization of biosimilars back in September 2011 [1]. It announced positive results from the completed phase III study for BI 695501 in patients with active rheumatoid arthritis (RA) in October 2016 [2].

The company also has a candidate bevacizumab biosimilar (BI 695502) in late stage development. Positive results for BI 695502 from its phase I INVICTAN-1 study were announced in November 2016 [3].

Bioisimilars rivals Amgen and Samsung Bioepis (a Biogen and Samsung joint venture) submitted their adalimumab biosimilar marketing applications to EMA for approval in December 2015 and July 2016, respectively [4, 5]. Meanwhile, FDA approved Amgen’s biosimilar adalimumab in September 2016 [6].

Related article
Boehringer Ingelheim stops biosimilar rituximab development

References
1.    GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim joins other Big Pharma going into biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-joins-other-Big-Pharma-going-into-biosimilars
2.    GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Boehringer’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Boehringer-s-adalimumab-biosimilar
3.    GaBI Online - Generics and Biosimilars Initiative. Positive results for etanercept and bevacizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-etanercept-and-bevacizumab-biosimilars
4.    GaBI Online - Generics and Biosimilars Initiative. Biosimilar adalimumab application submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-adalimumab-application-submitted-to-EMA
5.    GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis adalimumab biosimilar submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-adalimumab-biosimilar-submitted-to-EMA
6.    GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-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 © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: Boehringer Ingelheim

Comments (0)