Francesco Bandello

Aug 26, 2024 | nature.com | Ashish Sharma |Peter Kaiser |Frank G. Holz |Sobha Sivaprasad |Taku Wakabayashi |Nilesh Kumar | +3 more

The majority (95.2%) of the ophthalmologists were aware of all the ranibizumab biosimilars available in India. Biosimilar ranibizumab was the most common ranibizumab administered with 50–100% usage in 51% respondents whereas the proportion of originator usage was below 25% in the majority of practices (62.8%) (Fig. 1B).

Aug 3, 2024 | nature.com | Ashish Sharma |Taku Wakabayashi |Anat Loewenstein |Nilesh Kumar |Francesco Bandello

AbstractTo understand subfoveal neurosensory detachment flattening and observe (SNF-Ob) strategy and its relationship with visual acuity in the management of centre-involved diabetic macular oedema (Ci-DMO). This was a multicentric retrospective observational study. We reviewed data of 188 eyes of 130 patients who presented with Ci-DMO with subfoveal neurosensory detachment (NSD) and treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents or steroids.

Mar 4, 2024 | nature.com | Ashish Sharma |Nilesh Kumar |Francesco Bandello |Anat Loewenstein

India was the first country in the world to approve ranibizumab biosimilar. The Drug Controller General of India (DCGI) approved Razumab (Intas Pharmaceuticals Limited, Ahmedabad, India) in 2015 as the first biosimilar ranibizumab [1]. The innovator ranibizumab molecule (Lucentis, Genentech, USA) patent expired in June 2020 (USA) and July 2022 (EU) [2]. This has led to a flurry of new drug applications and approval of biosimilar ranibizumab especially in India.

Nov 4, 2023 | nature.com | Ashish Sharma |Anat Loewenstein |Nilesh Kumar |Francesco Bandello

In the past 2 years, there have been multiple approvals of ranibizumab biosimilars across the globe. There are some that are approved by the local regulatory authority of a country; for example, the Drug Controller General of India has approved two ranibizumab biosimilars (Ranieyes, by Lupin Ltd and Ranizurel by Reliance Life Sciences) in India [1]. The Ministry of Food & Drug Safety of South Korea approved CKD-701 by Chong Kun Dang Pharmaceutical Corp [2].

Aug 30, 2023 | nature.com | Ashish Sharma |Anat Loewenstein |Nilesh Kumar |Francesco Bandello

Biosimilar anti-VEGFs are emerging as a wave with a series of biosimilar ranibizumab approvals in the last 2 years across the globe by various regulatory agencies including the United States Food and Drug Administration (US-FDA) and European Medical Agency (EMA) [1]. Furthermore, multiple biosimilar aflibercept molecules are in the final stages of regulatory approval process [2]. Once the aflibercept patent expires, these molecules will be available for clinical use.