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Be Careful What You Wish For? FDA’s Biosimilars Naming Guidance Proposes…
Yesterday, the Food and Drug Administration (FDA) released much anticipated guidance on how they plan to address nonproprietary…
Biosimilars: Abbvie Finds Fault with Zarxio Label, Submits Citizen Petition
On June 2, AbbVie, Inc. submitted a citizen petition requesting that FDA require the approved prescription drug labeling…
District Court Denies Amgen’s Motion for Preliminary Injunction to Prevent…
The first U.S. biosimilar is one step closer to entering the marketplace. Last week, U.S. District Judge Richard Seeborg…
FDA Approves Sandoz’s Zarxio, The First Biosimilar Approved in the…
Today, the Food and Drug Administration approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the U.S. …
FDA Accepts Apotex’s Neupogen Biosimilar Application: Raises Issues…
Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim,…
Biosimilars: FDA Calls For Comment on Data Needed To Show a Product is…
2015 is poised to be a big year for biosimilars. For starters, FDA owes industry more guidance on “interchangeability” and the…
Biosimilars Update: FDA Staff Recommends Approval of First Biosimilar in…
FDA’s “Purple Book,” which lists all licensed biological products, currently has an empty column under the “biosimilar” heading,…
Biosimilars Update: FDA Releases “Purple Book”; Two Companies File…
Vaccines, allergy shots, blood components, and gene therapies are examples of biological products. Most biologics are produced in…
EFPIA Disapproves of French Off-Label Initiative
On July 8, 2014, the French National Assembly voted a draft law proposal that would potentially allow healthcare…
Recent Survey Shows the Need for Education on the Differences Between…
The North American for Continuing Medical Education, LLC (NACCME) recently announced the results of a survey of oncologists,…