Mylan, Lupin Receive European Approval for Etanercept Biosimilar

Mylan and Lupin announced that the European Commission has approved their etanercept biosimilar (Nepexto, YLB113), which references Amgen and Pfizer’s Enbrel for the treatment of immune-mediated inflammatory diseases, such as rheumatoid arthritis. The biosimilar received marketing authorization for all indications of the reference product.

“This milestone reflects a strong scientific program behind [YLB113] and commitment by our teams and our partner, Lupin, to bring the product to market as soon as possible. We look forward to launching Nepexto in the second half of this year,” said Mylan President Rajiv Malik, in a statement.

Etanercept is a tumor necrosis factor (TNF) inhibitor also used for the treatment of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, plaque psoriasis, and pediatric plaque psoriasis.

Lupin CEO Vinita Gupta expressed that this is the first biosimilar to receive regulatory approval in Europe for the India-based company. “Biosimilars like [YLB113] will play a critical role in expanding access to patients in Europe, providing an effective treatment for multiple therapies, including rheumatoid arthritis,” she said in the statement.

Lupin and Mylan have been in collaboration since 2018 to commercialize a biosimilar etanercept in several global markets.

YLB113 is the third etanercept biosimilar to receive approval in Europe and the fifth biosimilar approved for Mylan for the European market.

Lupin also received marketing approval for YLB113 in Japan in collaboration with YL Biologics in March 2019.

Clinical Equivalency

The regulatory approval comes after the Committee for Medicinal Products for Human Use recommended YLB113 for use after reviewing a biosimilarity assessment that included preclinical and clinical study results that demonstrated bioequivalence to the reference product.

Additionally, YLB113 demonstrated equivalence to reference etanercept in terms of efficacy, safety, and immunogenicity in a phase 3 clinical trial for patients with moderate to severe active rheumatoid arthritis.

In 2019, reference etanercept, marketed by Amgen and Wyeth Pharmaceuticals, grossed $9.6 billion in global sales, according to IQVIA. The drug generated $5 billion for sales in the United States alone.