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EMA approval for infliximab biosimilar Zessly Posted 13/04/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 March 2018 that it had recommended granting marketing authorization for the infliximab biosimilar Zessly.

Zessly (PF‑06438179) is produced by Sandoz, the generics division of Novartis. The company submitted its application for the infliximab biosimilar to EMA in June 2017 [1].

The product is a proposed biosimilar to Johnson & Johnson and Merck’s Remicade (infliximab), which had worldwide sales of US$9.3 billion in 2014, before the advent of biosimilars. The patents on Remicade will expire in the US in September 2018 and expired in Europe in February 2015 [2].

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 CHMP has recommended that Zessly be approved for all indications of its reference medicine. These include for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

The CHMP positive opinion is based on comprehensive clinical and non-clinical data, which is expected to confirm the biosimilarity of infliximab to the reference biological with analytical, preclinical and clinical data matching across quality, efficacy and safety. The clinical phase III confirmatory study in rheumatoid arthritis patients (REFLECTIONS B537‑02) 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 EU: Binocrit (epoetin alfa), Erelzi (etanercept), Omnitrope (somatropin), Rixathon (rituximab), Riximyo (rituximab) and Zarzio (filgrastim) [3]. The company also gained US approval for Zarxio (filgrastim-sndz) – the first biosimilar approved in the US – in March 2015 and for Erelzi (etanercept-szzs) in August 2016 [4]. It has also submitted applications for approval of its etanercept (GP2015) and rituximab (GP2013) biosimilars to the US Food and Drug Administration [5, 6] and for its etanercept (GP2015) and pegfilgrastim (LA‑EP2006) biosimilars to EMA [7, 8].

Sandoz says that it ‘is on track to launch several biosimilars of major oncology and immunology biologics by 2020’.

Related article
Biosimilars of infliximab

References
1. 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 Apr 13]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-infliximab-biosimilars-from-Sandoz-accepted-for-review-by-EMA
2. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13] Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for rituximab biosimilar from Sandoz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-rituximab-biosimilar-from-Sandoz
7. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar
8. GaBI Online - Generics and Biosimilars Initiative. EMA accepts biosimilar pegfilgrastim application from Sandoz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-biosimilar-pegfilgrastim-application-from-Sandoz

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Source: EMA, Sandoz

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