Pharmalot: We're Reading About a Lack of FDA Adcomms, FDA Loosening Biosimilar Rules, and More

Pharmalot: We're reading about a lack of FDA adcomms, FDA loosening biosimilar rules, and more

The FDA is easing some requirements for makers of copycat versions of costly biologic medications in a bid to create more competition

FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies

Biologics eat 51% of drug spending despite being 5% of prescriptions, but the FDA's new draft guidance hopes more competition can close that gap.

FDA Proposes New Guidance to Streamline Biosimilar Development and Reduce Costs

The U.S. Food and Drug Administration has released new draft guidance designed to streamline the development of biosimilar medicines, potentially reducing development costs and improving access to lower-cost biologic therapies. The agency’s proposal recommends eliminating certain clinical pharmacokinetic (PK) testing requirements when scientifically justified, which could reduce study costs by up to 50%—or roughly $20 million per program. Accord…

FDA takes further steps to streamline biosimilar development and make medicines more affordable

WASHINGTON, D.C. – The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs. In new draft guidance issued today, the agency recommended streamlining unnecessary clinical pharmacokinetic (PK) testing when scientifically justified. This change could save biosimilar developers up to 50% of their PK study costs…