Tag Archives: biosimilars

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

HTAs Impact on Biosimilars in Europe

Cuts in healthcare costs due to post-recession austerity programs mean favorable Health Technology Assessments (HTAs) are becoming crucial to the successful market launch of pharmaceuticals in Europe. HTAs backing reimbursement can be vital for new innovative medicines and also for biosimilars. EUnetHTA has been stepping up its efforts to achieve more consistency in the methodology […]
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FDA Guidances, OIG Investigations to Shape Drug Marketing, Research

Marketers may see further advice from the Food and Drug Administration in the coming year that clarifies how they can use social media. Priority topics:  presenting risk and benefit information in limited space; correcting independent/third party misinformation about a drug or medical device; and appropriate use of links, according to the agenda for the Center […]
Posted in Advertising, Biotech, E-Media, FDA, Legal, pricing, Regulatory, social media | Also tagged , , , , , , | Leave a comment
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