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EMA approval for etanercept and rituximab biosimilars Posted 28/04/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 April 2017 that it had recommended granting marketing authorization for the etanercept biosimilar Erelzi and for the rituximab biosimilars Rixathon and Riximyo.

All three biosimilars are produced by Sandoz, the generics division of Novartis. Erelzi (GP2015) is a biosimilar of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept), a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Enbrel is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Rheumatoid arthritis and psoriasis are estimated to affect around 1.3 million and 7.5 million people, respectively, in the US.

Rixathon and Riximyo (GP2013) are biosimilars of Roche’s MabThera/Rituxan (rituximab), a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

EMA’s CHMP has recommended that Erelzi be approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis. The committee also recommended that Rixathon and Riximyo, be approved for the treatment of non-Hodgkin's lymphoma, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. Rixathon is also intended for the treatment of chronic lymphocytic leukaemia.

The Marketing Authorization Application (MAA) submissions included data from two comprehensive development programmes in which analytical, preclinical and clinical  – including pharmacokinetic/pharmacodynamic – data were generated. The programmes, according to Sandoz, ‘demonstrated biosimilarity of biosimilar rituximab and etanercept to their respective reference medicines’.

The development programme for the etanercept biosimilar included an innovative phase III confirmatory safety and efficacy study in moderate to severe plaque psoriasis (EGALITY), which included three treatment switches between the reference medicine and biosimilar etanercept [1].

Studies within the biosimilar rituximab development programme included a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST‑RA)7 and a phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL)8.

The etanercept biosimilar (GP2015) was approved by the US Food and Drug Administration (FDA) in all five indications of the originator product (Enbrel) in August 2016 [2]. FDA has designated the placeholder non-proprietary name of etanercept-szzs for the product, which will also be called Erelzi in the US.

Sandoz currently markets three biosimilars worldwide [Binocrit (epoetin alfa), Omnitrope (somatropin) and Zarzio/Zarxio (filgrastim)] [3, 4]. The company also says that it ‘plans to launch three more biosimilars of major oncology and immunology biologicals across key geographies by 2020’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Sandoz etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 28]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Sandoz-etanercept-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar etanercept Erelzi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 28]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-etanercept-Erelzi
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 28]. 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 2017 Apr 28]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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Source: EMA

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