Biogen today announced that New citrate-free, low-volume formulation of its biosimilar drug adalimumab is available in Italyindicated in the EU for treatment of chronic immune-mediated inflammatory diseases (Imid), such as rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa in adults and adolescents, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, uveitis and pediatric uveitis. Complex pathologies involving over 2 million people in Italy, with a considerable impact on the quality of life of those who suffer from it and with consequent social effects. (VIDEO)
The reduced volume and the absence of citrates, which characterize the new formulation – reads a note – are able to offer patients a more comfortable injection procedure. The active ingredient of the new formulation has not changed compared to the formulation already approved in the European Union in 2018: the pharmacokinetic comparability between the two formulations was demonstrated in a randomized Phase 1 study. The safety and efficacy profiles of the two formulations of the biosimilar results are superimposable. The new formulation has room temperature stability (up to 25 degrees Celsius) extended to 31 days, thus offering more flexibility and freedom to patients.
“The formulation change of the adalimumab biosimilar allows for improve the treatment experiencein line with a patient-focused approach to managing complex diseases,” he explains Matteo Filippini, rheumatologist at the Spedali Civili of Brescia – such as rheumatological ones, which significantly affect the quality of life of those affected. The absence of citrates and the reduced volume make the injection procedure more comfortable for patients, both in terms of reduced injection time and less discomfort at the injection site, with potential clinical benefits, including an expected improvement in adherence to treatment”.
The diseases “chronic intestinal inflammation (Mici) – he adds Ambrogio Orlando, director of the Ibd Unit of the Ao Ospedali Riuniti Villa Sofia-Cervello of Palermo – accompany the patient throughout his life and determine the emergence of needs related to the definition of therapeutic procedures that take into consideration the needs of managing the disease in line with maintaining a good quality of life. The biosimilar drug adalimumab has long been a widely established therapeutic option, with the largest number of therapeutic indications for the first-line treatment of immune-mediated inflammatory diseases in all areas, from gastroenterology to dermatology and rheumatology. The low-volume and citrate-free formulation of this biosimilar therefore constitutes a further ally in the therapeutic panorama to respond to the needs of patients”.
With one of the largest portfolios of anti-TNF biosimilars in the EU, Biogen serves the treatment needs of more than 250,000 people worldwide and, since the launch of its three TNF-inhibiting biosimilars, has contributed to the reduction in healthcare costs across the European Union of over €7 billion. More and more people in Europe (+40%) have access to biological medicines thanks to the introduction of biosimilars Tnf inhibitors, intended for the treatment of Imid in rheumatology, dermatology and gastroenterology. Biosimilars play an essential role in reducing healthcare costs and expanding access to care by making less expensive biological treatments available to doctors and patients.
“The launch of the new low-volume, citrate-free formulation of our adalimumab biosimilar,” he said. Paolo Gili, Head of the Biosimilars Business Unit of Biogen Italia – demonstrates Biogen’s commitment to expanding the choices for patients and physicians, enabling them to adopt solutions adapted to different needs, optimizing disease management and improving the treatment experience. The new formulation of the adalimumab biosimilar complements our broad portfolio of TNF-inhibiting drugs and will help provide the scientific community with additional evidence supporting the efficacy and safety of biosimilars for the treatment of immune-mediated chronic inflammatory diseases in different age groups. age and for different levels of disease severity, while addressing the need to make injection procedures more comfortable.”