EMA recommends approval of etanercept biosimilar Nepexto Posted 03/04/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 March 2020 that it had recommended granting of marketing authorization for a biosimilar etanercept product.

The biosimilar etanercept, which will be called Nepexto (YLB113), has been developed by US-based drugmaker Mylan and its partner India-based generics maker Lupin. Mylan and Lupin made a deal to commercialize an etanercept biosimilar back in June 2018 [1].

The drug is a biosimilar of Amgen’s Enbrel (etanercept). Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. The positive opinion from EMA’s CHMP recommends approval of Benepali for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.

The positive CHMP opinion is 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 [2].

The CHMP positive opinion will now be considered by the European Commission (EC). Once approved the EC will grant a centralized marketing authorization for member countries of the European Union (EU). The decision on the EC’s approval is expected in May 2020.

Assuming it receives final EU approval, Nepexto will be the fifth biosimilar developed by Mylan to receive approval in Europe. The company received approval for its insulin biosimilar Semglee in March 2018; adalimumab biosimilar Hulio (FKB327) in September 2018; pegfilgrastim biosimilar Fulphila (MYL‑1401H) in November 2018 and trastuzumab biosimilar Ogivri (MYL‑1401O) in December 2018 [3].

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 [3].

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 [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan and Lupin make deal for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Lupin-make-deal-for-etanercept-biosimilar%20
2. GaBI Online - Generics and Biosimilars Initiative. Yoshindo and Lupin’s etanercept biosimilar completes trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Biosimilars/Research/Yoshindo-and-Lupin-s-etanercept-biosimilar-completes-trials
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for Lupin’s etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 3]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-Lupin-s-etanercept-biosimilar

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Source: EMA, Mylan

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