Evolution of Biosimilars in Ophthalmology
摘要
Anti-VEGF therapy has revolutionized the treatment of retinal vascular diseases since 2005. However, high financial burden due to need of repetitive therapy limits long-term compliance. Biosimilars have similar efficacy and safety akin to the innovator molecule at a much lower cost. India was the first country to approve and use the first biosimilar anti-VEGF (razumab, Intas Pharmaceuticals). This has made a significant change to the practice pattern in India for the retinal physicians and majority of them now use ranibizumab biosimilar than the originator molecule. Many ranibizumab biosimilar molecules have received approval by the US- Food and Drug Administration (US-FDA) and European Medical Agency (EMA) and are in clinical use successfully. Many countries have mandated biosimilar ranibizumab as the first line of step therapy. US-FDA has also approved five aflibercept biosimilar molecules over the last year. With the introduction of aflibercept-ayyh (Pavblu, Amgen, USA), clinical use of aflibercept 2mg biosimilars has now begun in the US, even though there are still ongoing patent litigations between the originator and biosimilar companies. Hopefully, these litigations will get sorted over course of time and, with the availability of multiple biosimilar anti-VEGF molecules, financial burden may come down on patients and healthcare systems significantly.