FDA Biosimilars Plan Draws From Experience With Generics

By Maria Doukas, Christopher Betti, Kathleen Sanzo, Jacqueline Berman and Michael Abernathy (August 20, 2018, 2:29 PM EDT) -- On May 11, 2018, President Donald Trump issued his blueprint to lower drug prices that describes the Administration's plan to reduce the price of prescription drugs by, among other actions, "[a]dvanc[ing] biosimilars and generics to boost price competition."[1] The blueprint "seek[s] to encourage innovation, while also promoting better price competition."[2] To help achieve the administration's goals, the U.S. Food and Drug Administration recently unveiled the FDA's Biosimilars Action Plan, which FDA Commissioner Scott Gottlieb called "an important piece" of the blueprint.[3][4] Noting the "anemic" competition for biosimilars with only three biosimilars currently marketed in the U.S. 11 being FDA approved at the time of the BAP release,[5] Commissioner Gottlieb stated the BAP would help the FDA achieve the goals of "mak[ing] the process for developing biosimilars more efficient" and "promoting competition and affordability across the market for biologics and biosimilar products."[6]...

Law360 is on it, so you are, too.

A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.


A Law360 subscription includes features such as

  • Daily newsletters
  • Expert analysis
  • Mobile app
  • Advanced search
  • Judge information
  • Real-time alerts
  • 450K+ searchable archived articles

And more!

Experience Law360 today with a free 7-day trial.

Start Free Trial

Already a subscriber? Click here to login

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!