Pathway for Biosimilars Act gives agencies 'flexibility'

Share this article:
Rep. Anna Eshoo (D-CA) and Rep. Joe Barton (R-TX) have introduced legislation that would create a regulatory pathway for the FDA to approve follow-on or generic biologics. Their “Pathway for Biosimilars Act” would give the agency “flexibility” to determine the level of clinical testing needed and allow innovators 12 years of data exclusivity.
Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Researchers hit links for charity

The PMR Charities Golf Classic teed up more than $20,000 for St. Jude Children's Research Hospital.

FDA to review Neupogen biosimilar

Novartis subsidiary Sandoz announced Thursday that the FDA has agreed to review its filgrastim biosimilar which is already approved in 40 countries.

FDA approves a new painkiller

Targiniq ER combines the prescription opioid oxycodone and naloxone, which is often used to treat overdoses.