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Gambro Satellite SymposiumGambro - Your home of INNOVATION
Innovation - Putting ideas into action to make a genuine difference
Incremental Innovation
From Complexity to Simplicity – a Personal Experience
Advanced Simplicity –Building a bridge between theory and practice Chairs: Jitka Pancířová, Anki Davidson Congress Hall, 6.9., 17:15
Sandoz Satellite SymposiumNew opportunity in the treatment of renal anaemia: Binocrit®, the first ESA biosimilar The successful introduction of Binocrit®, the first ESA to be approved under EMEA biosimilar guidelines, is an important milestone in the treatment of renal anaemia. For specialists in renal care it is important to understand answers to key questions related to biosimilar medicines in Europe.
Biosimilar medicines are EMEA-authorised, new versions of current biopharmaceutical medicines whose patents have expired. Biopharmaceutical medicines are produced by living organisms; they can be sensitive to manufacturing changes and so, biosimilar versions may not be not identical copies of the existing biopharmaceutical medicines. Biosimilars are approved on the basis that they show, within clearly defined guidelines, comparability to these existing medicines. Their development is dependent on a high level of technology and requires considerable investment. It is necessary for manufacturers of biosimilars to demonstrate, through direct comparison in clinical studies, therapeutic equivalence - clinical efficacy and safety profile - with existing biopharmaceutical medicines. The quality of a medicine to be approved under biosimilar guidelines is also assessed against the same standards that are applied to existing biopharmaceutical The development programme for Binocrit® was successful in demonstrating its efficacy in the treatment of anaemia in haemodialysis patients with chronic kidney disease and in cancer patients with chemotherapy-induced anaemia. In addition, the results demonstrate an expected safety profile for Binocrit®. The clinical development programme, which was commenced only after state-of-the-art analytical tests secured the quality of the drug product, included five pharmacokinetics studies and two major clinical phase III studies. This group of clinical studies aimed to demonstrate the safety profile and efficacy of HX575 in the treatment of anaemia and the programme results provide clinical evidence pivotal in its authorisation, as the world’s first European Medicines Agency biosimilar guidelines-approved erythropoeisis-stimulating agent (ESA). The introduction of EMEA biosimilar pathway-approved represents an important opportunity for European healthcare systems, with the potential to offer increased access to high quality high technology-based medicines, including those for the treatment of renal anaemia, to patients, nurses, physicians and the healthcare systems.
Treating renal anaemia with ESA biosimilars: key questions for nurses
Guide for Renal Nursing Specialists: understanding the EMEA biosimilar-approval process
Understanding the Clinical evidence: introduction of ESA, Binocrit® Chairs: Lesley Bennett & Rebecca Kinton Meeting Hall 1, 8.9., 12:30 |
