EC approval for etanercept biosimilar Nepexto

Biosimilars/News | Posted 03/07/2020 post-comment0 Post your comment

The European Commission (EC) has granted marketing authorization for the etanercept biosimilar Nepexto (YLB113), developed by US-based drugmaker Mylan and its partner India-based generics maker Lupin. V13H09

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 on 20 May 2020 follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 27 March 2020 [1], which was based on a biosimilarity assessment which included preclinical and clinical studies demonstrating bioequivalence to the reference product. In addition, a phase III clinical study in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to the reference product in terms of efficacy, safety and immunogenicity [1].

Nepexto has been approved for the treatment of ankylosing spondylitis, juvenile rheumatoid arthritis, psoriatic arthritis, rheumatoid arthritis, spondylarthropathies and psoriasis.

Nepexto is the third etanercept biosimilar to receive approval in Europe. Benepali, produced by Samsung Bioepis, was the first to be approved in January 2016, followed by Erelzi from Sandoz [2].

Lupin has also received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its etanercept biosimilar YLB113 in Japan [3].

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1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of etanercept biosimilar Nepexto []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for Lupin’s etanercept biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from:

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Source: EMA

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