Subscription Required

Only paid subscribers* to Specialty Pharmacy News can access this Web portal with three years of back issues, searchable article archives and other valuable resources.

Subscribers to Specialty Pharmacy News receive

  • 12 monthly issues packed with news and strategies on this increasingly vital sector in health business, delivered First Class by U.S. Mail and electronically (optional),
  • E-News Alerts whenever important news breaks, and
  • Access to a subscriber-only Web page with:
    • Searchable archives of past articles,
    • Convenient library with PDFs of back issues,
    • Recent stories of interest grouped for convenient reading, and
    • Regular postings from Managing Editor Angela Maas.
View a sample and get more information
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

Be sure to visit often, for PDFs of issues, archives of articles and data, and more!

Please e-mail me with your comments on the last issue of Specialty Pharmacy News, story ideas for future issues, or any other suggestions you have that can make the newsletter more useful for you.

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Long-Awaited Biosimilar Interchangeability Draft Guidance Is Out

FDA finally unveils interchangeability draft guidance for biosimilars, expects “that applications generally will include data from a switching study or studies in one or more appropriate conditions of use,” among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 www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid...

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 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...

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 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...

It's quick and easy to sign up for FREE access to AISHealth.com!

Why do I need to register?