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FDA OKs first biosimilar of Roche’s blockbuster AMD drug Lucentis

pharmaphorum

Samsung Bioepis and Biogen have claimed the first FDA approval for a biosimilar version of Roche and Novartis’ Lucentis (ranibizumab) for leading causes of blindness, raising the prospect of a cheaper treatment option for US patients. Sales reached a peak in 2019, when Roche booked $1.8 billion, but fell back to $1.4

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Pressure rises on Lucentis, as Coherus biosimilar gets FDA nod

pharmaphorum

The US FDA has approved a new biosimilar of Roche and Novartis’ blockbuster ophthalmology therapy Lucentis – Coherus BioSciences’ Cimerli – which its developer claims is the first to be fully interchangeable with the originator product. Roche has US marketing rights to the drug, and booked $1.3

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Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz

pharmaphorum

Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the European Commission approved Samsung Bioepis’ copycat drug Byooviz. Sales reached a peak in 2019, when Roche booked $1.8 billion in sales from the drug while Novartis made $2.1 billion for Roche and $1.9

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Roche eyes October decision by FDA for wet AMD implant

pharmaphorum

The original formulation has started to lose patent protection however, and a gaggle of drug developers – including Samsung Bioepis/Biogen, Hospira and Formycon/Bioeq – are already preparing to enter the US market with lower-cost biosimilars , with the first rivals expected to launch before year-end. Last year, Roche booked around $1.5

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Exclusive Coverage: Global PHT Expo & Summit 2023

PharmaShots

Addepalli Veeranjaneyulu and Shubhadeep Debabrata Sinha introduced the session by describing the function of PV in the safety profiles of biosimilars. To provide the audience with an Indian viewpoint, the presenters pointed out the country's requirements for biosimilar PV.

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Rx & Calc - TDM calculator via Microsoft Excel and Open as App Learning Module - Questions bank for PRP training Optimizing PDF (eBooks) - Teach you how to create bookmarks in PDF for faster navigation Pilleye - Pill counting app Add Website to Home Screen - For fast access QR Code, Shorten URL and Links in One Place - Discussing some useful tools (..)