COMPANIES THERAPY AREAS PREPARATIONS CONTACT SERVICE Home PREPARATIONS Generics / biosimilars Register Generics & Biosimilars We are already offering patients access to high-quality drugs with our optimized product portfolio of generics and biosimilars. Find out here what generics and biosimilars mean. What are generics? Generics are drugs that contain the same active ingredients as corresponding first-party products. Once the patent protection of high-priced patent-protected drugs has expired, generics can be made available for patient care. This creates competition and competition leads to falling drug prices. Generics thus enable an affordable supply of pharmaceuticals in Germany and sustainably relieve our health system. Furthermore, generics must meet the strict regulations of the Federal Institute for Drugs and Medical Devices (BfArM) or the corresponding sister authority at EU level (EMA) in order to be approved. Here quality, effectiveness and safety are comprehensively checked and ensured. What are biosimilars? Biosimilars are biological drugs that are manufactured with the help of modern biotechnology and may be approved after the patent protection of the original drug has expired. Every biosimilar is unique. For companies, this means high requirements for the manufacture of these drugs, for clinical studies in which their effectiveness is proven, for ensuring the highest quality in the high-tech production processes, right up to a thorough and scientific evaluation by the European approval authority (EMA). Difference Between Biosimilars and Generics Biosimilars are not generic drugs. The classic drugs are defined by a clear chemical structure. The active ingredients of the biosimilars are always individual and not completely identical to the original or first biopharmaceutical. Darüber hinaus werden die Eigenschaften biologischer Arzneimittel stets durch einen komplexen Herstellungsprozess bestimmt, z. B. in der Verwendung unterschiedlicher Organismen, in denen der Wirkstoff bzw. das Protein produziert wird, oder Verfahren zur Abtrennung und Aufreinigung des Proteins. Daher müssen für die Biosimilars klinische Studien durchgeführt werden, damit ihre Wirksamkeit und Sicherheit nachgewiesen wird; erst danach kann eine Zulassung durch die Europäische Zulassungsbehörde (EMA) ausgesprochen werden. Trotzdem können die Hersteller den Patienten einen kostengünstigeren Preis und damit nachhaltigen Zugang zu hochmodernen Arzneimitteln anbieten, da die Entwicklungskosten für ein Biosimilar entfallen und somit eine bezahlbarere Arzneimittelversorgung ermöglicht wird. Fußbereichsmenü Unternehmen Über uns Geschäftsfelder Karriere Presse/Newsroom Therapiegebiete Krebserkrankungen Neutropenie Immuntherapie b. Organtransplantation Präparate Übersicht Generika/Biosimilars Rabattverträge Kontakt Kontaktformular Nebenwirkungs- meldungen Medizinisch- wissenschaftliche Anfragen Qualitäts- beanstandungen Service Übersicht Disclaimer Impressum Datenschutz Transfer of Value 2018 Transfer of Value 2019 Transfer of Value 2020 Accord Healthcare GmbH • Hansastraße 32 • 80686 München­ • Tel.: +49 (0) 89 700 9951-0­ • Fax: +49 (0) 89 700 9951-66 If you click on "Accept all cookies", you consent to the storage of cookies on your device. This enables us to offer you the best possible service and permanently improve user-friendliness. Under "Cookie Settings" you can revoke your consent at any time or make individual cookie settings. Please click on "Reject all" if you want to object to the use of cookies that are not technically required. Further detailed information can be found in our data protection declaration Refuse all Accept all cookies Cookie settings