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Are Biobetters Better?
Biosimilars and biobetters are both variants of a biologic drug, however, while biosimilars are close copies of the originator, biobetters have been improved, for example, in terms of efficacy, safety, tolerability or dosing regimen.Regulators consider biobetters as new products and so afford them the same patent protection as any originator, however, this means they require the same clinical and non-clinical data packages. Conversely, a reduced clinical data package is an attractive element for the development of biosimilars.Given the cost of development and the time pressure to bring a biobetter to market before biosimil...
Source: EyeForPharma - July 3, 2017 Category: Pharmaceuticals Authors: James Wright Source Type: news

Mircera (Methoxy Polyethylene glycol-epoetin beta) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - May 9, 2016 Category: Drugs & Pharmacology Source Type: news

Roche sues Intas Pharma over Mircera anaemia drug patent
Swiss biotechnology giant Roche has sued Ahmedabad-based drug maker Intas Pharmaceuticals in Delhi High Court, alleging infringement of its patent rights over Mircera. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 18, 2016 Category: Pharmaceuticals Source Type: news

Roche enters into exclusive license agreement with Galenica for the commercialisation of Mircera in the United States
Roche announced today that it has entered into an exclusive licence agreement with Galenica for the commercialisation of Roche's drug Mircera (methoxy polyethylene glycol-epoetin beta) in the US and Puerto Rico. Mircera is a prescription medicine used to treat symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients and represents an ideal complement to the existing product portfolio of Galenica for patients with CKD and iron deficiency. (Source: Roche Investor Update)
Source: Roche Investor Update - May 28, 2015 Category: Pharmaceuticals Source Type: news

Mircera (Methoxy Polyethylene glycol-epoetin beta) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 16, 2014 Category: Drugs & Pharmacology Source Type: news