Enbrel Biosimilar Nepexto Approved in Europe for JIA, Other Inflammatory Disorders

Enbrel Biosimilar Nepexto Approved in Europe for JIA, Other Inflammatory Disorders
0
(0)

The European Commission has approved Nepexto, a biosimilar of Enbrel (etanercept), for the treatment of juvenile idiopathic arthritis and other inflammatory disorders.

Nepexto is expected to be available to patients in the European Union in the second half of the year. The decision was supported by the recent approval recommendation from the Committee for Medicinal Products for Human Use, an arm of the European Medicines Agency.

The approval of Nepexto, codeveloped by Mylan and Lupin Limited, includes all other indications for Enbrel in Europe, namely rheumatoid arthritispsoriatic arthritisplaque psoriasis (including the pediatric form of the disease), and both ankylosing spondylitis and non-radiographic axial spondyloarthritis — the two forms of axial spondyloarthritis.

“We are truly delighted with this approval. Nepexto is our first biosimilar to receive regulatory approval in Europe. With this important milestone, we bring an affordable biosimilar to the European market through our partner Mylan. Biosimilars like Nepexto will play a critical role in expanding access to patients in Europe,” Vinita Gupta, CEO of Lupin, said in a press release.

The approval was based on both preclinical and clinical results, including a Phase 3 trial (2015-002809-12) in adults with moderate to severe rheumatoid arthritis. The findings confirmed that Nepexto and Enbrel have comparable safety, efficacy, and immunogenicity — the capacity to induce an immune response.

Biosimilars have similar active properties, and comparable safety and efficacy to reference biological therapies. Like generics, biosimilars are manufactured by a different company after the original product’s patent expires and are usually sold at significantly lower prices.

In Europe, two other biosimilars to Amgen’s Enbrel are already approved — Erelzi, by Novartis, and Benepali, by Samsung Bioepis. The treatments are designed to block tumor necrosis factor (TNF), a pro-inflammatory protein.

“The approval of Nepexto, our biosimilar etanercept, is a positive step forward as we work to broaden our biosimilars franchise offerings and do our part to increase access to biologic treatments for patients in many European countries.” said Rajiv Malik, Mylan’s president. “We look forward to launching Nepexto in the second half of this year.”

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.
Total Posts: 11

José holds a PhD in Neuroscience from Universidade of Porto, in Portugal. He has also studied Biochemistry at Universidade do Porto and was a postdoctoral associate at Weill Cornell Medicine, in New York, and at The University of Western Ontario in London, Ontario, Canada. His work has ranged from the association of central cardiovascular and pain control to the neurobiological basis of hypertension, and the molecular pathways driving Alzheimer’s disease.

×
Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.

How useful was this post?

Click on a star to rate it!

Average rating 0 / 5. Vote count: 0

No votes so far! Be the first to rate this post.

As you found this post useful...

Follow us on social media!

We are sorry that this post was not useful for you!

Let us improve this post!

Tell us how we can improve this post?