Lupin Limited and Mylan N.V. have launched Nepexto®, a biosimilar version of etanercept, in Germany, marking Lupin’s first biosimilar approval in Europe and the product’s first market entry on the continent.
Nepexto® has been approved for all therapeutic indications of the reference biologic Enbrel® and is indicated for a broad range of immune-mediated inflammatory diseases, including moderate to severe rheumatoid arthritis, juvenile idiopathic arthritis from the age of two, psoriatic arthritis, axial spondyloarthritis, and plaque psoriasis in adults as well as children and adolescents.
Established role of etanercept in inflammatory diseases
Etanercept, a Tumor Necrosis Factor (TNF) inhibitor, has been used in Germany since 2000 and remains a mainstay in the treatment of chronic inflammatory and autoimmune conditions. By targeting TNF, a key cytokine in the inflammatory cascade, the therapy helps control disease activity and improve long-term outcomes.
Prof. Dr. med. Rieke Alten, Chief Physician, Department of Internal Medicine (Rheumatology, Clinical Immunology, Osteology) at Schlosspark-Klinik Charlottenburg, Berlin, said TNF inhibitors such as etanercept allow clinicians to “intervene precisely in the inflammatory process.”
“In patients with moderately severe to severe rheumatoid arthritis who do not respond adequately to basic therapeutics, remission of the disease through therapy with etanercept in combination with methotrexate is a quite realistic therapeutic goal,” Alten said. She added that rheumatologists have long-standing experience with etanercept’s efficacy and safety profile, making it a preferred option when “safety first” is the guiding principle.
Patient-friendly administration
Nepexto® is available as an injectable solution in both a pre-filled pen and a pre-filled syringe. According to the companies, patient data show high acceptance of the easy-to-use, latex-free pre-filled pen, particularly for self-administration, which may support better treatment adherence.
Regulatory approval and cost considerations
The biosimilar received marketing authorisation from the European Commission on June 4, 2020, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The CHMP concluded that analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with the reference product, Enbrel®.
Nepexto® is positioned as a cost-effective alternative to the originator biologic, with comparable efficacy and safety, and is expected to contribute to more sustainable treatment options within Germany’s healthcare system.
India–Germany pharmaceutical cooperation backdrop
The launch comes against the backdrop of growing India–Germany cooperation in the pharmaceutical and life sciences sector, spanning drug manufacturing, regulatory alignment, research collaboration and supply chain resilience. Germany remains one of Europe’s most important markets for Indian pharmaceutical companies, particularly in generics, biosimilars and active pharmaceutical ingredients (APIs).
At an institutional level, India and Germany have been strengthening collaboration through government-led dialogues, industry associations and regulatory exchanges, with a shared focus on quality standards, patient safety and innovation-driven manufacturing. Biosimilars are increasingly seen as a key area of convergence, as both countries seek to balance affordability with high regulatory and clinical benchmarks.
Company perspectives
Thierry Volle, President, EMEA at Lupin, said the German launch marked a significant milestone for the company’s biosimilar strategy in Europe. “Nepexto® is our first biosimilar to receive regulatory approval in Europe,” he said, adding that biosimilars would play a vital role in expanding access to effective therapies, including for rheumatoid arthritis.
Dr. Maximilian von Wülfing, Managing Director of Mylan Germany, said Germany was selected as the first European country to introduce Nepexto®. “The approval of Nepexto® by the European Medicines Agency once again underlines the scientific success of Mylan’s biologics program,” he said.
Nepexto® becomes Mylan’s second immunology biosimilar in Germany, following Hulio®, further expanding its treatment portfolio for immune-mediated diseases.
