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EC approval for infliximab biosimilar Zessly Posted 25/05/2018

Sandoz, the generics division of Novartis, announced on 24 May 2018 that it had received European Commission (EC) approval for its infliximab biosimilar Zessly (PF‑06438179).

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 23 March 2018 [1].

The EC’s approval is based on a comprehensive data package confirming that Zessly matches the safety, efficacy and quality of the reference biological, Johnson & Johnson and Merck’s Remicade (infliximab).

The EC approval was based on review of a comprehensive development programme, including analytical, preclinical and clinical data, which confirmed Zessly matched its reference medicine, Johnson & Johnson and Merck’s Remicade (infliximab), in terms of safety, efficacy and quality. It included data from the clinical phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02), which met its primary endpoint, demonstrating equivalent efficacy of Zessly to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.

Sandoz already has six biosimilars approved in the European Union: Binocrit (epoetin alfa), Erelzi (etanercept), Omnitrope (somatropin), Rixathon (rituximab), Riximyo (rituximab) and Zarzio (filgrastim) [2]. The company also gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), in March 2015 – the first biosimilar approved in the US and for its etanercept biosimilar, Erelzi (etanercept-szzs) in August 2016 [3]. It has also submitted applications for approval of its pegfilgrastim (LA-EP2006) and rituximab (GP2013) biosimilars to the US Food and Drug Administration (FDA) [4, 5]. Its pegfilgrastim application, however, was rejected by FDA in July 2016 [6].

Zessly marks the third approval for a Sandoz biosimilar in the last 12 months and Novartis says that it expects several more major oncology and immunology launches globally by 2020.

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References
1.  GaBI Online - Generics and Biosimilars Initiative. EMA approval for infliximab biosimilar Zessly [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-infliximab-biosimilar-Zessly
2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25] Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25] Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
4.  GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar
5.  GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
6.  GaBI Online - Generics and Biosimilars Initiative. FDA rejects Sandoz’s biosimilar pegfilgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Sandoz-s-biosimilar-pegfilgrastim-application

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Source: EMA,Novartis, Sandoz

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