FDA Finalizes Guidance Documents on Biosimilars
The U.S. Food and Drug Administration(FDA) has finalized three guidance documents outlining its expectations for biosimilars.
Biosimilars Debut in the U.S.
In light of the angst and hand-wringing over the soaring costs of biologic drugs that are alleged to be contributing to the unsustainability of biologic treatments, the U.S. Food and Drug Administration (FDA) approval of the first biosimilar in the U.S. was welcome news to many.
Biosimilars 20/20 Conference Scheduled for June
The Biosimilars 20/20 Conference, at two-day event that will provide an indepth look into the future of the biosimilars market and address challenges of implementation, is scheduled for June3 and 4 at The Hub in Philadelphia, Pa.
Biosimilars: The Race for Approval
As the approval of biosimilars looms, debate continues over whether they should be substituted for biopharmaceuticals, how to legislate them and how they should be named.
