Generics New Importance in CDER

September 11, 2012
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

Recently reported are the changes made to the FDA’s Center for Drug Evaluation and Research….most significant is that the Office of Generic Drugs is becoming a “super office” whereby it will oversee other offices and report directly to Janet Woodcock, the director of CDER.

In a letter published by PharmaManufacturing, Woodcock says that with the passage of the Generic Drug User Fee Amendments of 2012 (GDUFA), and given that nearly 80% of all prescriptions in the U.S. are now of generic drugs, it makes sense to give generic drugs a superior position­ in FDA.

In GDUFA, generic drugmakers would pay $1.58 billion in user fees. They had previously been exempt.

Meanwhile, in the area of biosimilars, which are generic versions of large molecules, Woodcock also generated some coverage on her FDA website, CDER Director’s Mailbag. The question: Can you tell us about the FDA’s position on biosimilars? You can read her answer here.

Apparently, Woodcock needs to spread the word on biosimilars, if you can count on a report just release by Industry Standard Research. According to its survey respondents from investigative sites, roughly half are not familiar with biosimilars. However, they would be excited if a biosimilar protocol came across their desk. In addition, the ISR Report noted that the surveyed sites have conducted 19 studies in the past 24 months, and of those five or six has been for a generic product, and one for a biosimilar.

The global biosimilar market was $2.5 billion in 2011, and is expected to grow at a CAGR of 8% between 2012 and 2016.