Tag Archive: follow-on biologics

Mar 09 2012

After all the talk, where are we with biosimilars?


In this highly charged political climate, no news broadcast is complete without some mention of healthcare.  Frequently the focus is on healthcare costs, which is one reason that the government charged the FDA in 2010 with creating the 351(k) approval process for biosimilars (generic versions of biologically manufactured products).  Well-known marketed biologics in the U.S. …

Continue reading »

Jul 14 2011

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

Continue reading »

Mar 25 2010

Biotech Wins Protection From Biosimilars

Love is the power to see similarity in the dissimilar. – Theodor Adorno When President Obama signed the healthcare reform legislation into law, he also handed a major victory to biotech companies. Unless you’ve been stranded on a deserted island with only a volleyball for company, you’re aware that most of the press and analysis …

Continue reading »