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At the beginning of the year, there was a great deal of anticipation about when the first biosimilar would be approved in the U.S…And then it happened…On March 6, the FDA has approved Novartis/Sandoz's Zarxio (filgrastim-sndz), a biosimilar of Amgen's Neupogen…And as of Thursday, September 3, Zarxio officially hit the U.S. market at a 15% discount to Neupogen… to gain clarification around several key issues concerning biosimilars, we spoke with Dr. Bert Liang, Chair of the Biosimilars Council…

1. Last month, you responded to the decision from the Federal Circuit Court of Appeals that recognized the ‘patent dance’ as optional by applauding the decision. Can you explain your reaction?
2. When would it be beneficial for a biosimilar company to provide a complete copy of its biosimilar application to the reference manufacturer upon filing?
3. You have indicated that the proposed biosimilar naming convention put forth by the FDA in which originator products and biosimilars share the same core name and have different suffixes. Please tell us why you disagree with that.
4. What type of approach to naming would work in your opinion?
5. How do you see the public hearing hosted by the FDA playing out? Who are your allies in this issue?
6. Can the U.S. look to Europe as a model for the evolving role of biosimilars?

Ashley Talamo, Publisher: Pharmacy Times...(PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more. (video)

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• Have You Taken the Pledge to Help Prevent Prescription Drug Abuse in Your Community?
• NABP Report Stresses Need for Accountability in Enforcing Internet Policies to Protect the Public From Rogue Internet Pharmacies
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QS1 announced…that it would be partnering with…FDS to brings(bring) its customers… business intelligence software myDataMart...pharmacy owners can receive detailed analytics into the state of their business operations and potentially increase their Centers for Medicare and Medicaid Services Star ratings,..aid in monitoring adherence among patients,..

• Amendment of Nevada Administrative Code 453.510 - Schedule 1 - The proposed amendment to NAC 453.510 will add newly identified synthetic drugs to the list of controlled substances listed on Schedule 1, and provides for other matters properly related thereto.
• A REGULATION relating to pharmacy; revising provisions governing the licensure of a third-party logistics provider; and providing other matters properly relating thereto.
• A REGULATION relating to the practice of pharmacy; requiring certain entities collecting controlled substances to provide certain notification and a copy of a certain federally required form to the State Board of Pharmacy; clarifying standards for the disposal of controlled substances; and providing other matters properly relating thereto.
• A REGULATION relating to pharmacy; requiring, under certain circumstances, an outsourcing facility to obtain a license from the State Board of Pharmacy as a manufacturer; and providing other matters properly relating thereto.

Third-year pharmacy students at the Fairleigh Dickinson University School of Pharmacy will soon attend sessions at The Medicines Company’s patient simulation lab…students will be exposed to simulated hospital experiences in cardiac catheterization units and operating rooms using high-tech mannequins…also gives students a chance to see real-time blood pressure readings and simulated patients’ adverse effects from medication.

340B Program "mega-guidance" recently released by the Health Resources Services Administration sets stricter standards for contract pharmacy use…This proposed guidance follows a 2011 report from the Government Accountability Office recommending better oversight of the 340B Drug Pricing Program to ensure that funds are used in a manner consistent with the program’s intent…primarily focuses on entity eligibility and program integrity measures.

Dispensing medical marijuana may soon become an issue for specialty pharmacy…first medical marijuana capsules were made available online to patients in Europe…marks the first in a long list of goals set by the company (MMJ PhytoTech Limited) and sets the tone for how the cannabidiol market is anticipated to play out.

Kristene Diggins, MBA, manager of professional practice at MinuteClinic, gives counseling points that pharmacists should provide to diabetic patients.  (video)

Chris Hatwig, MS, FASHP of Apexus discusses what HRSA policy updates, including 340B "mega guidance," are poised to affect health-system pharmacists.  (video)