EC approval for etanercept biosimilar Erelzi

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EC approval for etanercept biosimilar Erelzi

Biosimilars/News | Posted 07/07/2017 0 Post your comment

Sandoz, the generics division of Novartis, announced on 27 June 2017 that it had received European Commission (EC) approval for its biosimilar etanercept product Erelzi.

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 21 April 2017 [1].

Erelzi has been approved for use in all indications of the originator biological, Amgen/Pfizer’s Enbrel (etanercept). The indications approved are rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis and paediatric plaque psoriasis.

The approval was based on a ‘comprehensive development program[me] generating analytical, preclinical and clinical — including pharmacokinetic (PK) — data’. This programme, according to Sandoz, ‘demonstrated that Erelzi matches its reference medicine in terms of safety, efficacy and quality’.

The approval marks Sandoz’s fifth biosimilar approval in the European Union (EU). It received approval for its somatropin biosimilar (Omnitrope) in April 2006, for its epoetin alfa biosimilar (Binocrit) in August 2007 and for its filgrastim biosimilar (Zarzio) in February 2009 [2]. Then, in June 2017, the company received EC approval for its rituximab biosimilar, Rixathon [3]. The company also received a positive opinion from EMA’s CHMP for another rituximab biosimilar (Riximyo) in April 2017 [1].

Sandoz announced on 27 June 2017 that it had launched its etanercept biosimilar, Erelzi, and rituximab biosimilar, Rixathon, in the UK.

Lastly, Sandoz received approval for Erelzi from the US Food and Drug Administration on 30 August 2016 [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for etanercept and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-etanercept-and-rituximab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for rituximab biosimilar Rixathon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-rituximab-biosimilar-Rixathon
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar etanercept Erelzi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-etanercept-Erelzi

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Source: Novartis, Sandoz