November 20, 2015
A Politico Pro-Health panel on biosimilars invited straight talk from FDA Director Janet Woodcock, MD, who acknowledged the need for a safe, incremental approach to adopting biosimilar medications.
November 12, 2015
Much more than simply a sticker on a medicine bottle, drug labels – or “prescribing information”—provide physicians with crucial information about medical therapies.
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.
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.
September 11, 2015
Biosimilar cost savings have arrived. But they are proving much less robust than proponents had hoped.
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.
September 1, 2015
Australian pharmacists could soon substitute a biosimilar infliximab for its reference product without prescribing physicians’ –or even patients’—knowledge.
September 1, 2015
By David Charles, MD and Mary Ann Chapman, PhD More than five years have passed since Congress approved an abbreviated…
August 28, 2015
The FDA has issued new guidance that proposes giving distinct non-proprietary names to biologics and biosimilars.
August 11, 2015
Colombian regulators’ ill-defined “alternative approach” to approving biosimilar medicines has the country’s patients unsettled.
