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June 2017

Recent Stories

From Specialty Pharmacy News - In a closely watched case, the U.S. Supreme Court issued a ruling June 12 that is likely to bring biosimilars onto the U.S. market at a faster pace than had been anticipated recently. The latest move in the lawsuit (No. 15-1309) between Sandoz Inc. and Amgen Inc. over Sandoz’s Zarxio (filgrastim-sndz), a biosimilar of Amgen’s Neupogen (filgrastim), clarifies issues within the language of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Perhaps most noteworthy, the ruling says that biosimilar applicants need not wait for FDA approval to notify reference drug manufacturers of their intent to market the drugs, allowing the products to potentially launch sooner than a lower court had ruled they could. Read more

Vertex Pharmaceuticals Inc. recently added Maxor National Pharmacy Services, LLC to its… Read more

Following Amgen Inc.’s release of data from a long-awaited outcomes trial on… Read more

As more generic competitors to Novartis Pharmaceuticals Corp.’s bestseller Gleevec (imatinib mesylate)… Read more

From the Editor

Welcome to your Specialty Pharmacy News subscriber-only Web page

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June 12, 2017
SCOTUS Rules for Sandoz in Notice of Commercial Marketing

SCOTUS rules in Sandoz v. Amgen that applicants do not need to wait for FDA approval before giving notice of commercial marketing https://www.supremecourt.gov/

March 22, 2017
Bonus Insight Reports for Subscribers

Several special reports covering key areas of concern to today’s health care executives are now available in your Subscriber Library. These original reports from the AIS Health editorial team are filled with business insights and practical advice on the pharmacy issues that affect payers and providers the most. Access them at https://aishealth.com/newsletters/specialtypharmacynews/bonus-insight-re....

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Long-Awaited Biosimilar Interchangeability Draft Guidance Is Out

FDA finally unveils interchangeability draft guidance for biosimilars, expects “that applications generally will include data from a switching study or studies in one or more appropriate conditions of use,” among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

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