'

DrugWonks on Twitter

DrugWonks on Facebook

CMPI Videos


Video Montage of Third Annual Odyssey Awards Gala Featuring Governor Mitch Daniels, Montel Williams, Dr. Paul Offit and CMPI president Peter Pitts


Indiana Governor Mitch Daniels


Montel Williams, Emmy Award-Winning Talk Show Host


Paul Offit, M.D., Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, for Leadership in Transformational Medicine


CMPI president Peter J. Pitts


CMPI Web Video: "Science or Celebrity"

Social Networks



Please Follow the Drugwonks Blog on Facebook, Twitter, LinkedIn, YouTube & RSS




Add This Blog to my Technorati Favorites
Political Blogs - BlogCatalog Blog Directory

Tabloid Medicine

Please Check out the latest book by
Dr. Robert Goldberg Ph.D.
"Tabloid Medicine"

Check Out CMPI's Book

Physician Disempowerment:
A Transatlantic Malaise

Edited By: Peter J. Pitts
Download the E-Book Version
Here

CMPI Events

Donate

CMPI Reports

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP

Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum

Club For Growth
CNEhealth.org

Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare

Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst

The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
 


And the word on biosimilar nomenclature is ... Suffix

2017-01-13 | Peter Pitts

We've called for this from the start and now it's reality. In final guidance released Thursday on naming of biologic drugs, FDA reiterated that each biologic should receive a non-proprietary "core name" plus a unique four-letter suffix that is devoid of meaning. Each biologic and biosimilar would receive a hyphenated "proper name" joining the core name with the suffix.

The convention is designed to differentiate among non-interchangeable reference products and biosimilars.
The agency said it is also still considering the suffix format for interchangeable products.

In an agenda released Wednesday, FDA said it plans to publish guidance this year addressing "considerations in demonstrating interchangeability with a reference product."
FDA said it intends to apply the naming system prospectively, and will "communicate with companies that have pending applications to discuss implementation."


In the final guidance, FDA said it is "continuing to consider" how to implement the naming convention for existing biologics, and "in the near term, intends to assign distinguishing suffixes to a limited group of these products."
FDA said the unique suffixes should prevent "inadvertent substitution" among biologics and clarify adverse event reporting. The agency encouraged "routine use" of designated suffixes in ordering, prescribing, dispensing and pharmacovigilance of biologics, independent of a product's approval pathway or time of approval.

Well done FDA.