U.S. FDA shared a post on X:
“FDA takes major step to streamline biosimilar medicines, which are like ‘generic’ versions of biologic drugs.
New draft guidance recommends reducing unnecessary clinical pharmacokinetic (PK) testing when scientifically justified-potentially saving developers ~$20M (up to 50% of PK study costs) and helping lower drug costs for patients.”
FDA Issues 81 New Product-Specific Guidances to Advance Generic Drug Development
