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February 2017

Recent Stories

From Specialty Pharmacy News - The FDA is standing firm in its preference for using four-letter suffixes as distinguishing identifiers for all biologic drugs, including both biosimilars and their reference products. However, at least one industry group estimates that implementation of this approach will cost the health care system billions of dollars. In *Nonproprietary Naming of Biological Products *(82 Fed. Reg. 4345), published Jan. Read more

With the amount of reported direct and indirect remuneration (DIR) in Medicare… Read more

While many stakeholders within the health care industry hailed President Barack Obama’s… Read more

From new advances in medications including cancer drugs and biosimilars to changing… Read more

From the Editor

Welcome to your Specialty Pharmacy News subscriber-only Web page

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January 17, 2017
Long-Awaited Biosimilar Interchangeability Draft Guidance Is Out

FDA finally unveils interchangeability draft guidance for biosimilars, expects “that applications generally will include data from a switching study or studies in one or more appropriate conditions of use,” among other criteria

January 12, 2017
FDA Finalizes Naming Guidance for Biologics, Biosimilars

In final guidance, FDA says all biologics, not only biosimilars, will have four-letter suffixes; agency still considering “appropriate suffix format” for interchangeable biosimilars

December 28, 2016
FDA Issues More Biosimilar Guidance

FDA issues guidance on clinical pharmacology data needed to show a product is biosimilar to its reference drug

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