Tag Archives: biosimilars
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 biosimilars.
Posted in Biotech, FDA, Guest Blog, IP, Legal, Regulatory, Strategy, Technology Also tagged FDA, Legal, Regulatory Guidelines 1 Comment
Biosimilars Spend to Reach $2.5 Bln by 2015: IMS
Global spending on biosimilars is expected to reach between $2 and $2.5 billion by 2015, up from $311 million in 2010, according to an IMS forecast. Total spend on biologics is expected to climb as high as $200 billion.
On a call with reporters yesterday, Murray Aitken, executive director of the IMS Institute for Healthcare Informatics, [...]
Posted in Agency Insight, Biotech, Emerging Markets, Europe, Strategy Also tagged forecast, IMS Health 2 Comments
Innovators: Take a Leaf from the Generic Industry Book
No-one can accuse the European generic industry of indolence. It supplies huge quantities of medicines to European healthcare suppliers — its volume is estimated at around a half of the market. It is accounting for a growing share of marketing authorization applications in Europe. And its industry association, the EGA, has turned it from being [...]
Posted in Europe, Regulatory, healthcare Also tagged anti-competitive strategies, antitrust, EC, EGA, EU, European Generics, generics, healthcare Leave a comment
MedImmune Bets Its Fate on “Biobetters”
AstraZeneca’s biologics shop makes a decisive move in the biosimilars market.
MedImmune, the biologics shop bought by AstraZeneca (AZ) for a staggering $15 billion in 2007 promising one new drug a year for the foundering British firm, has made precious little news since the deal. But all of a sudden the post-Labor Day wires were crackling [...]

Global Biosimilars Market to Reach $2.4 Billion in 2013