Tag Archives: biosimilars

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

Global Biosimilars Market to Soar to $24 Billion by 2019

Frost & Sullivan: Strong Pipeline of Monoclonal Antibodies (mAbs) Biosimilars in the US and Europe Lends Impetus to Global Market The market is expected to soar from $1.2 billion of 2013 to $24 billion in 2019 LONDON – 29th January 2014 – The imminent entry of several companies, including big pharma, small biotech and generic […]
Posted in Biotech, Europe, Global, Strategy | Also tagged , | 1 Comment

FDA Gets More Funding, IPAB Gets Less

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays, the Food and Drug Administration did fairly well in gaining additional funds, along with user fee revenues that had been put on […]
Posted in FDA, healthcare, Legal, Regulatory, Safety | Also tagged , , , , , , , | Leave a comment

Global Biosimilars Market to Reach $2.4 Billion in 2013

By Adeline Siew, Editor, Pharmaceutical Technology Europe. The global market for biosimilar drugs has been forecasted to be worth $2.445 billion this year, according to a new report by British market research specialist Visiongain. The growth represents a 20% increase from last year and accounts for approximately 2% of the overall biologics market. Moreover, the […]
Posted in Biotech, Global, Guest Blog, R&D | Also tagged , , | Leave a comment

U.S. Biosimilars Under Threat?

by D’vorah Graeser, Graeser Associates International While the FDA continues to develop its guidance for U.S. biosimilars, including a one-day public hearing on May 11, 2012, the basic legal underpinnings of biosimilars in the U.S. may be under threat, as the Supreme Court debates the healthcare law, a large chunk of which includes provisions for […]
Posted in Biotech, FDA, Guest Blog, IP, Legal, Regulatory, Strategy, Technology | Also tagged , , | 1 Comment
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