Navigation Links
Mylan Supports Generic Drug Industry's Call on FDA to Uphold Consistent, Proven International Standard for Biosimilar Naming
Date:9/23/2013

PITTSBURGH, Sept. 23, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today expressed support for the Generic Pharmaceutical Association's (GPhA) filing of an official Citizen Petition with the Food and Drug Administration (FDA) detailing the industry's position on biosimilar naming. The petition recommends that all biosimilars approved by the agency share the same international non-proprietary name (INN) as the biologic products to which they refer. A drug's INN serves to clearly and universally state a medicine's main substance or ingredient – for example, Lipitor®'s INN, or generic name, is Atorvastatin Calcium. An approved biosimilar product will have been shown through rigorous physicochemical and functional testing to be as close to the reference product as the reference product is to itself from lot to lot, but with more affordability. It is therefore critical for the medical community to continue identifying biosimilars using the same naming convention as other medicines available to patients today.

Mylan CEO Heather Bresch commented: "Mylan's mission to set new standards in health care and expand access to high quality medicine is aligned with GPhA's Citizen Petition to FDA regarding the use of consistent international standards for biosimilar naming. The use of consistent INN's ensures patient safety as it helps to protect patients from concerns such as double dosing where two highly similar products may be prescribed."

The importance of consistent INN's to patient safety can be illustrated by the more than 150 different biologic INN's with over 250 different trade names on the market today. If each biologic were to have just four biosimilar options (i.e. fewer competitors than the average path taken by small molecules which have an average of 12 manufacturers per product), 600 new INN's wo
'/>"/>

SOURCE Mylan Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Mylan Launches Generic Version of Zyprexa® Tablets
2. Mylan and Pfizer Announce Epinephrine Auto-injector Settlement Agreement with Teva
3. Mylan Reports Q1 2012 Adjusted Diluted EPS of $0.52, an 18% Increase Over Prior Year Quarter
4. Mylan Launches Generic Lipitor® in Five European Countries
5. Mylan Launches Generic Version of Plavix® Tablets
6. Mylan Sponsors Drug Store News and Pharmacist Society to Provide a New Business Networking Platform for Pharmacy Schools and Students
7. Mylan Launches Generic Version of Viramune® Tablets
8. Mylan Launches Generic Version of Bonviva® Film Coated Tablets in the UK and Italy
9. Mylan Announces Settlement Agreement in Patent Infringement Litigation Relating to Sunovions Brovana® Product
10. Mylan Announces Settlement Agreement in Litigation Relating to its Generic Xopenex®
11. Mylan Launches Generic Version of Lipitor®
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... , July 25, 2014 Leading events ... is returning for the seventh year to São Paulo, ... th August 2014. The event will co-locate with Food ... most comprehensive meeting point for the pharmaceutical industry. ... 25 countries for pharmaceutical sales are now exploring the ...
(Date:7/25/2014)... Dr. Michael Gabriel of a prominent Staten ... study, which shows how grief in pregnancy may cause obesity ... According to US News , "Unborn children ... others to grow up overweight or obese, even if that ... specific types of stress that caused obesity: "Children whose biological ...
(Date:7/24/2014)... July 24, 2014  PTC Therapeutics, Inc. (NASDAQ: ... host a webcast conference call to report its second ... the company,s business and outlook on Thursday, August 7, ... the market. The call can be ... (international) five minutes prior to the start of the ...
Breaking Medicine Technology:CPhI South America 2014 Launches with Generics Showing Huge Growth 2CPhI South America 2014 Launches with Generics Showing Huge Growth 3CPhI South America 2014 Launches with Generics Showing Huge Growth 4Dr. Michael Gabriel of GPM Pediatrics, a Noted Staten Island Pediatrics Clinic, Comments on Study, Which Names Grief as a Cause of Obesity in Children 2
... Inc. joined the National Senior Games Association to launch the ... a global leader in musculoskeletal health, Zimmer is proud to ... athletic achievements of 356 athletes assembled for this year,s winter ... year,s games as they demonstrate what can be achieved by ...
... Sysmex America, Inc., a global leader in ... today announces the release of the newest version ... The Sysmex WAM Management Reports Module features new ... enable the user to quickly develop on-demand reports, ...
Cached Medicine Technology:Zimmer Sponsors Winter National Senior Games 2Sysmex Announces Newest Version of Clinical Laboratory Management Software 2
(Date:7/28/2014)... TherapySites, the leading website ... today its affiliation with the Illinois Association for ... allows TherapySites to continue to extend their online marketing ... offers. , “There has been a fundamental shift in ... nearly 3 billion Internet users, it is so important ...
(Date:7/28/2014)... July 28, 2014 Footwear etc. is ... styles from Mephisto. With shoes, sandals, and boots that ... products continually provide handmade comfort shoes and ... women have come to rely on the superb value, ... Mephisto shoes and sandals contain the highest quality materials ...
(Date:7/28/2014)... (PRWEB) July 28, 2014 To commemorate ... Editorial Board of Living with a Disability magazine ... disabling digestive disorders that include hepatitis, gastrointestinal hemorrhage, inflammatory ... , The important new article highlights that, in the ... afflicted with hepatitis and other disabling conditions related to ...
(Date:7/28/2014)... (PRWEB) July 28, 2014 According to the ... a comprehensive relationship guide that helps women easily get the ... , Vkool reveals in its review that this book ... eyes of their man. The book also instructs them how ... Vkool informs in its Drama Method review that this book ...
(Date:7/28/2014)... Suwanee, GA (PRWEB) July 28, 2014 ... across the nation gathered at the MGE Management Experts ... officials and community leaders joined the Dentists to raise ... of the Boys and Girls Clubs and Youth Programs ... thousands of young people with books and audio books ...
Breaking Medicine News(10 mins):Health News:TherapySites (Websites for Therapists) Partners with the Illinois Association for Marriage and Family Therapy 2Health News:Footwear etc. Highlights Phenomenal Models of Mephisto Shoes 2Health News:Footwear etc. Highlights Phenomenal Models of Mephisto Shoes 3Health News:Living with a Disability Magazine Marks World Hepatitis Day on July 28 with New Article on Disabling Digestive Disorders 2Health News:Living with a Disability Magazine Marks World Hepatitis Day on July 28 with New Article on Disabling Digestive Disorders 3Health News:The Drama Method Pdf Review Exposes Aaron Fox's Relationship Guide – Vkool.com 2Health News:The Drama Method Pdf Review Exposes Aaron Fox's Relationship Guide – Vkool.com 3Health News:Mitul R. Patel, DDS Successfully Attacks a Major Source of Economic Destruction in the Battle Against Illiteracy and Poverty 2Health News:Mitul R. Patel, DDS Successfully Attacks a Major Source of Economic Destruction in the Battle Against Illiteracy and Poverty 3
... a new study from the Journal of Bone and ... fasciitis who perform manual plantar fasciitis stretching exercises, as opposed ... Study details and findings: , A ... were randomly assigned to two groups. Acute is defined ...
... Nov. 3 (HealthDay News) -- Friendly discussions with other people ... are competitive in tone aren,t helpful, finds a new study. ... the way you do when you,re making friends, can provide ... at the Institute for Social Research at the University of ...
... a new clinical practice guideline for the nutritional and ... with diabetes mellitus. The guideline features a series of ... The guideline is published in the November 2010 issue ... ( JCEM ), a publication of The Endocrine ...
... HealthDay Reporter , WEDNESDAY, Nov. 3 (HealthDay News) ... treatment for men with prostate cancer, use declined drastically. ... -- androgen-deprivation therapy -- still received it, researchers report in ... of Medicine . "Probably what we,re witnessing here is ...
... CINCINNATIResearchers at the University of Cincinnati (UC) and the Cincinnati ... of chronic kidney disease patients who are prescribed therapies for ... This report was published in the Nov. 2 online edition ... study, led by researchers at UC and the Cincinnati VA, ...
... Stereotactic body radiotherapy (SBRT), a radiation therapy procedure pioneered ... precisely delivers a large dose of radiation to tumors, ... when combined with the chemotherapy Cetuximab, according to researchers ... presented today at the American Society for Radiation Oncology ...
Cached Medicine News:Health News:Plantar fasciitis? Stretching seems to do the trick 2Health News:Good Conversation Can Boost Brain Power, Study Finds 2Health News:Experts issue recommendations for treatment of post-bariatric surgery patients 2Health News:Use of Prostate Cancer Treatment Fell When Medicare Paid Docs Less 2Health News:Use of Prostate Cancer Treatment Fell When Medicare Paid Docs Less 3Health News:Medication adherence improves blood pressure control in chronic kidney disease 2Health News:Combining radiation therapy, chemotherapy safely treats head and neck cancer patients 2
... and balanced for smooth, one-handed control. Reflexion's ... reducing fatigue in even the longest procedures. ... to easily steer the catheter through its ... finger. Reflexion's auto-lock technology keeps the catheter ...
... technologies - Quantum™ LEAP® balloon material ... unite in the Quantum™ Maverick® Balloon ... force balloon with exceptional deliverability. Easier ... shaft technology improves trackability and crossability ...
... Libert Coronary Stent System ... of lesion access and ... a low crossing profile, ... catheter, the performance of ...
... colonies, rows, and microplatesthat is the area ... is becoming an ever-increasing force. Ergonomics (reduced ... main reason that the Multichannel Research model ... pipette provides effective, precise, and rapid processing ...
Medicine Products: