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April 2016

Recent Stories

From Specialty Pharmacy News - In a little more than a year after the FDA approved the first biosimilar, Zarxio (filgrastim-sndz), reference drug Neupogen (filgrastim), the agency has approved a second drug that used the 351(k) approval pathway. On April 5, the FDA approved Celltrion, Inc.’s biosimilar Inflectra (infliximab-dyyb). The infusible monoclonal antibody is a biosimilar version of Janssen Biotech, Inc.’s Remicade (infliximab), which received its initial FDA approval in 1998. Read more

CMS’s recently proposed rule that would test different reimbursement tactics in Medicare… Read more

On March 8, CMS unveiled a proposed multipronged approach that would test… Read more

Aetna Inc. is continuing to broaden its oncology care management approach with… Read more

From the Editor

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April 6, 2016
FDA Approves Second Biosimilar

The FDA approves Celltrion’s Inflectra for all indications of the reference product, Janssen Biotech’s Remicade; drug is second FDA-approved biosimilar, first monoclonal antibody www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm

March 31, 2016
FDA Issues More Biosimilars Draft Guidance

FDA releases draft guidance on biosimilar products’ labeling, gives 60-day comment period http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati...

March 8, 2016
CMS Proposes Expanding Value-Based Approach to Medicare Part B

CMS proposed demo project for Medicare Part B includes changing ASP + 6% to ASP + 2.5% plus a $16.80 flat fee payment http://tinyurl.com/jgxx5cp

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