Tag Archives: biosimilars
By Jill Wechsler | Published: July 25, 2014
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 […]
By Pharm Exec | Published: June 17, 2014
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.
By Guest Blogger | Published: May 12, 2014
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.
By Pharm Exec | Published: March 21, 2014
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 […]
By Pharm Exec | Published: February 28, 2014
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.