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 arthritis, psoriatic arthritis, plaque 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.”
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?