Nepexto, a biosimilar of Enbrel (etanercept), is now available in Germany for patients with juvenile idiopathic arthritis (JIA) and other inflammatory conditions, according to Lupin Limited and Mylan, the treatment’s developers.
“We are excited to bring Nepexto in Germany,” Thierry Volle, president of Europe, the Middle East and Africa at Lupin, said in a press release.
“Nepexto is our first biosimilar to receive regulatory approval in Europe,” Volle said. “This launch is a remarkable milestone for our biosimilar group and we are glad that we are able to bring an affordable biosimilar to the European market through our partner Mylan.”
Germany becomes the first European country where the therapy is available.
Specifically, Nepexto is indicated in Europe for the treatment of juvenile psoriatic arthritis, as well as polyarticular and extended oligoarticular JIA, in patients who have had an inadequate response to, or are intolerant to methotrexate. However, while treatment can be started at age 2 in polyarticular and oligoarticular JIA, patients with juvenile psoriatic arthritis can only take Nepexto from age 12.
The therapy also can be used in individuals with enthesitis-related JIA from age 12 when conventional therapy is not possible.
In addition to JIA, and similar to Amgen’s Enbrel, Nepexto is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and both ankylosing spondylitis and non-radiographic axial spondyloarthritis — the two types of axial spondyloarthritis.
Nepexto comes as a solution for injection in either a pre-filled pen or a pre-filled syringe. According to the companies, data indicate a high acceptance rate for self-injection with the pre-filled pen, which may lead to better treatment adherence.
The launch of Nepexto in Germany follows this year’s approval of the treatment by the European Commission. That approval was based on evidence that Nepexto and Enbrel have comparable safety, efficacy, and immunogenicity — the capacity to induce an immune response. Preclinical and clinical data, including a Phase 3 trial (2015-002809-12) in adults with moderate-to-severe rheumatoid arthritis, contributed to this conclusion.
Biosimilars share similar properties, safety, and efficacy as a reference biological treatment. Akin to generics for conventional medications, biosimilars are often introduced as a means of lowering the cost and increasing the availability of a treatment to patients.
Both Nepexto and Enbrel, as well as two other biosimilars to Enbrel — Erelzi by Novartis, and Benepali by Samsung Bioepis — block the activity of the pro-inflammatory protein tumor necrosis factor (TNF).
“TNF inhibitors such as etanercept [Enbrel] make it possible to intervene precisely in the inflammatory process,” said Rieke Alten, MD, PhD, chief physician in the department of internal medicine at the Schlosspark-Klinik Charlottenburg, in Berlin.
“Rheumatologists particularly like to opt for etanercept when ‘safety first’ is the top priority,” Alten said. “Besides rheumatoid arthritis, this TNF inhibitor is also firmly established in other rheumatological indications.”
Mylan’s other treatment for immune-related diseases, Hulio, is a biosimilar of AbbVie‘s Humira (adalimumab), approved in the European Union and the U.S.