Biologics

Billing Code Proposal Raises Patient Safety Concerns

September 24, 2015

J-Codes, the billing codes used for medical therapies and procedures, could impact how well physicians and health care systems can monitor patient responses to biological medicines as more biosimilars enter the U.S. market.

U.S. Senators Press FDA Director on Unresolved Biosimilar Policy Issues

September 21, 2015

The Senate Subcommittee on Primary Health and Retirement Security’s September 17 hearing featuring FDA Director Janet Woodcock, MD, resulted in a packed hearing room—and hopes that FDA guidance on unresolved policy issues affecting biosimilars will materialize sooner rather than later.

IfPA Releases Policy Update on Biosimilars

September 10, 2015

Five years after the federal government approved an abbreviated regulatory pathway for biosimilars, physicians and patients still lack clarity on a number of core issues.