FDA accepts applications for adalimumab and trastuzumab biosimilars

Biosimilars/News | Posted 02/02/2018 post-comment0 Post your comment

Samsung Bioepis and Sandoz announced on 20 December 2017 and 16 January 2018, respectively, that the regulatory submissions for their proposed trastuzumab (SB3) and adalimumab (GP2017) biosimilars had been accepted by the US Food and Drug Administration (FDA).

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The trastuzumab product (SB3) from Samsung Bioepis is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had worldwide sales of CHF 6.8 billion in 2016. The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [1].

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Samsung Bioepis says SB3 ‘is the first oncology biosimilar candidate submitted for regulatory review in the US’. If approved, SB3 will be commercialized in the US by Merck, which is known as MSD outside of the US and Canada. The company already received European Commission approval for its trastuzumab biosimilar Ontruzant (SB3) in November 2017 [2]. It also received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for Samfenet (SB3) in November 2017 [3].

The adalimumab product (GP2017) from Sandoz, the generics division of Novartis, is a proposed biosimilar to AbbVie’s Humira (adalimumab), which had worldwide sales of US$16.1 billion in 2016. The patents on Humira expired in the US in November 2017 and in Europe in June 2017 [1]. 

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 biosimilar application for GP2017 includes data from a pharmacokinetic study in healthy volunteers and a phase III confirmatory safety and efficacy study in patients with moderate to severe chronic plaque-type psoriasis (ADACCESS).

Sandoz also submitted an application for approval of its adalimumab biosimilar (GP2017) to the European Medicines Agency (EMA) in June 2017 [4].

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1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 2]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant
3. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 2]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-approved-in-South-Korea
4. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and infliximab biosimilars from Sandoz accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 2]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-infliximab-biosimilars-from-Sandoz-accepted-for-review-by-EMA

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Source: Samsung Bioepis, Sandoz

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