An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review

Abstract

Biological therapies have revolutionized the treatment of disease across a number of therapeutic areas including retinal diseases. However, on occasion, such treatments may be relatively more expensive compared to small molecule therapies. This can restrict patient access and treatment length leading to suboptimal clinical outcomes. Several biosimilar candidates of ranibizumab and aflibercept are currently in development and the first biosimilar of ranibizumab received EMA approval in August and FDA approval in September 2021. Biosimilars are biological medicines that are highly similar to an already-approved biological medicine (reference product). The physicochemical and clinical similarity of a biosimilar is determined by a rigorous analytical and clinical program, including extensive pharmacokinetic and pharmacodynamic analysis with phase III equivalence studies where appropriate. These phase III studies are carried out in a patient population that is representative of all of the potential approved therapeutic indications of the originator product and the most sensitive for detecting potential differences between the biosimilar and the reference product. Biosimilars have been used successfully across a wide range of therapeutic areas for the past 15 years where they have achieved substantial cost savings that can be reinvested into healthcare systems without affecting the quality of patient care. The current review provides an introduction to biosimilars with the aim of preparing retinal specialists for discussing these products with their patients.

Ocular Delivery of Therapeutic Agents by Cell-Penetrating Peptides

“…Since intravitreal injection of anti-VEGF drugs is the gold standard for therapies of eye diseases, such as wet AMD, DME, and DR, biosimilars for successful anti-VEGF drugs (ranibizumab, bevacizumab, and aflibercept) have been developed and tested in clinical trials [ 135 , 136 ]. CKD-701 (Chong Kun Dang Pharmaceutical, Seoul, South Korea) is biosimilar for ranibizumab.…”

Anti-VEGF-Therapie bei der neovaskulären altersabhängigen Makuladegeneration

“…In der Gruppe der VEGF-Inhibitoren sind inzwischen Biosimilars zugelassen worden [18,19], weitere Substanzen befinden sich in der klinischen Prüfung [20]. Hierbei werden die regulatorischen Vorgaben eingehalten [21].…”

“…Für die Therapieentscheidung soll zudem das Sicherheitsprofil des jeweiligen Medikaments miteinbezogen werden, da besonders bei Brolucizumab medikamentenspezifische intraokulare Entzündungen beobachtet wurden [28] und für Faricimab noch keine längerfristigen Sicherheitsdaten vorliegen. Der Prozess unterscheidet sich entsprechend den regulatorischen Vorgaben von FDA und EMA (Directive 2004/27/EC) von der Zulassung eines neuen Wirkstoffs [20,21] Folgende Behandlungsstrategien wurden in den früheren nAMD-Stellungnahmen bereits ausführlich dargestellt [14,15].…”

“…Der Prozess unterscheidet sich entsprechend den regulatorischen Vorgaben von FDA und EMA (Directive 2004/27/EC) von der Zulassung eines neuen Wirkstoffs 20 , 21 :…”

Ergänzende Stellungnahme zu den IVOM-Medikamenten zur Therapie des diabetischen Makulaödems mit fovealer Beteiligung

“…Biosimilars: Biosimilars von Ranibizumab sind inzwischen für das diabetische Makulaödem mit Foveabeteiligung zugelassen worden 1 , 2 , weitere Substanzen befinden sich in der klinischen Prüfung 3 . Langzeitdaten zur Sicherheit liegen nicht vor.…”