Etanercept Biosimilar Is Recommended for Use in European Union

March 27, 2020
The Center for Biosimilars

Mylan and Lupin have gained the necessary recommendation to begin marketing their etanercept biosimilar in Europe.

Nepexto, an etanercept biosimilar, has gained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending use of the product.

Nepexto has received a positive opinion for all indications of the reference product (Enbrel), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and nonradiographic axial spondyloarthritis), plaque psoriasis, and pediatric plaque psoriasis, according to Mylan NV and Lupin Limited, which have partnered in the development of the biosimilar.

“This milestone brings us 1 step closer to bringing an affordable biosimilar to etanercept to the European market through our partner Mylan,” said Vinita Gupta, chief executive officer of Lupin, in a statement. The companies began collaborating in 2018 to bring an etanercept biosimilar to the European market.

Enbrel, marketed by Amgen and Wyeth Pharmaceuticals, had sales of roughly $9.6 billion globally in 2019, according to IQVIA. In the United S, the comparable revenue figure was $5 billion.

The EMU committee opinion was based on a bioequivalence assessment that included preclinical and clinical studies. In addition, a phase 3 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, the statement said.

There are 2 approved etanercept biosimilars in the US: Samsung Bioepis’ Eticovo and Sandoz’ Erelzi. However, neither has launched. Erelzi received FDA approval in 2016 and has been delayed by litigation. Eticovo was approved in 2019, and no launch date has been announced.

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