Tag Archives: biosimilars

Sandoz Wins Biosimilar Filing Race

 After months of speculation about prospects for biosimilar development in the U.S., Novartis announced July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the […]
Posted in FDA, R&D, Safety | Also tagged , , , | Leave a comment

Increase of Biosimilars Will Have “Negative Impact”

A new report from GlobalData states that the increase of biosimilars will have a negative impact on the biologics market after 2019. The report cites patent expirations of branded biologics and regulatory clarification as reasons for the prediction that biosimilars will capture the market share after 2019.
Posted in Biotech, Events, Gene therapy, Global | Also tagged , | Leave a comment

Eight Ingredients for a Successful Oncology Drug Development Recipe

by Matthew Cook and Sebastien Morisot In light of the risks and challenges inherent in the development of oncologics, some biopharma companies are beginning to question whether oncology remains an attractive therapeutic area in which to invest limited research, development, and commercialization resources.
Posted in Agency Insight, Biotech, Europe, FDA, Gene therapy, Guest Blog, leadership, Market Access, Orphan Drugs, pricing, R&D, Regulatory, Sales | Also tagged , | Leave a comment

European Physicians Have "Insufficient Knowledge of Biosimilars"

European physicians have insufficient knowledge of biosimilars, according to a survey carried out by the Alliance for Safe Biologic Medicines (ASBM). Only 22% of physicians consider themselves “very familiar” with this  category of medicines, and while a majority (54%) have a “basic understanding” of biosimilars, 24% of participants could not define or have not heard about […]
Posted in Biotech, Europe, Events, Gene therapy, Global | Also tagged , , | Leave a comment

AbbVie, Amgen, and Roche Most Exposed to Biosimilar Competition

While biosimilar products have been launched in Asia and Europe, they are at least three years away in the US, according to a new report on the global biosimilar drugs market.
Posted in Biotech, Gene therapy | Also tagged , , , | Leave a comment
  • Categories

  • Meta