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].

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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

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