Navigation Links
Janssen Pharmaceutical Companies of Johnson & Johnson Submit Citizen Petition to the U.S. FDA Regarding Naming of Biosimilars
Date:1/8/2014

WASHINGTON, Jan. 8, 2014 /PRNewswire-USNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) asking the agency to require biosimilars to bear nonproprietary names that are similar to, but not the same as, those of their reference products or of other biosimilars. The Petition states that distinguishable names are essential for enhancing patient safety and to ensure effective pharmacovigilance. 

"Ensuring biosimilars bear distinguishable names is of critical importance for patient safety," said Jay P. Siegel, M.D., Chief Biotechnology Officer and Head, Scientific Strategy and Policy, Johnson & Johnson.  "Names that are similar but not the same will appropriately reflect the legal and scientific reality that biosimilars are similar to but not the same as their reference products or other biosimilars."   

As FDA continues to implement the Biologics Price Competition and Innovation Act, the question of how biosimilars will be named must be addressed.  This question is currently being evaluated and will be addressed by the World Health Organization (WHO) and health authorities around the world.  Janssen submitted its Citizen Petition to communicate the company's position that requiring distinguishable names for biosimilars is critical for the safety of patients globally.

According to the Janssen Citizen Petition, the naming of biosimilars could have important patient safety implications beyond the name itself, including pharmacovigilance, product switching and extrapolation of indications.  Patients, their physicians and regulatory authorities such as the FDA need to know precisely which biological product has been used to
'/>"/>

SOURCE The Janssen Pharmaceutical Companies of Johnson & Johnson
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Janssen Research & Development Submits XARELTO® (rivaroxaban) to U.S. FDA for the Treatment and Prevention of Recurrent Venous Thromboembolism
2. Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin to Treat Patients with Type 2 Diabetes
3. Janssen Announces Initiation Of Phase 3 Development Program For Sirukumab In Rheumatoid Arthritis
4. Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab
5. West Announces Agreement with Janssen Biotech to Develop and Commercialize a New Self-injection Technology
6. Janssen Announces Collaboration with Vertex on Phase 2 Study to Investigate an All-Oral Regimen of Simeprevir (TMC435) and VX-135 for Treatment of Hepatitis C
7. Janssen and Johnson & Johnson to Provide Webcast Presentation of Immunology Pivotal Phase 3 Data Being Presented at the American College of Rheumatology Annual Meeting
8. Efficacy and Safety Data from Phase 2B Trials of Janssens Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual Meeting of the American Association for the Study of Liver Diseases
9. Janssen Research & Development Announces Establishment of Global Cross-Pharmaceutical Clinical Trial Investigator Databank
10. Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes
11. Janssen Labs at San Diego Expands to Add Concept Lab and Open Collaboration Space to Accommodate Individual Entrepreneurs and Additional Life Science Start-Ups
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/2/2015)... Conn. , July 2, 2015 Numotion,s ... Executive Officer announced that Tamas Feitel has ... Feitel joins Numotion after a highly successful 18 year ... leadership roles driving strategy, profitability, and productivity to result ... most recent position was Chief Financial Officer for GE ...
(Date:7/2/2015)... July 2, 2015 The report ... Heterofermentative), Species (Lactobacillus, Pediococcus & Enterococcus), Enzymes (Fibre-digesting & ... to 2020", Silage Inoculants & Enzymes Market is expected ... of 4.0% from 2015 to 2020. ... spread through 194 P ages and ...
(Date:7/2/2015)... julio de 2015 BGI anunció hoy que ... alto rendimiento en Hong Kong ... (CAP). La instalación de BGI en Hong Kong ... próxima generación que recibe la certificación CAP en ... en prácticas de laboratorio clínico. Junto con el exitoso ...
Breaking Medicine Technology:Numotion Names Tamas Feitel Chief Financial Officer 2Silage Inoculants & Enzymes Market Worth $489.05 Million by 2020 2Silage Inoculants & Enzymes Market Worth $489.05 Million by 2020 3Silage Inoculants & Enzymes Market Worth $489.05 Million by 2020 4BGI recibe la acreditación del College of American Pathologists (CAP) 2
... NAGOYA, Japan, June 23 Although previous studies,suggest ... length,growth of the eye in children with progressing ... evident. Using a rigorous study design,and precise optical ... in Madrid are undertaking the Myopia Control with,Orthokeratology ...
... Calif., June 23 Alexza,Pharmaceuticals, Inc. (Nasdaq: ... of its Phase 2a clinical trial of Staccato(R) ... the 50th Annual Scientific Meeting of,the American Headache ... Place in Boston, MA. The oral platform abstract ...
Cached Medicine Technology:Menicon Undertakes With the Novovision Clinic a Paediatric Myopia Control Clinical Trial 2Alexza Pharmaceuticals to Present AZ-104 Phase 2a Clinical Data at the American Headache Society Annual Scientific Meeting 2
(Date:7/3/2015)... ... July 03, 2015 , ... ... place on June 25, 2015 at 1:00pm. The Association welcomed speaker C. Daniel ... to injured bicyclists and practical points of investigating these types of cases. , ...
(Date:7/3/2015)... ... July 03, 2015 , ... " Selfie on a Stick ” ... latest and coolest technology products available to consumers. Amanda Forstrom, a technology expert and ... sticks are great for documenting memories. , Almost every smartphone has an incredibly powerful ...
(Date:7/2/2015)... ... , ... sweetFrog Enterprises, LLC. is pleased to announce the opening of its newest location in ... State. The premium frozen yogurt chain was listed as #22 on the Inc. 500 list ... Village at Bachman Lake, is located at:, 3701 W. Northwest Highway, STE 430, Dallas, TX ...
(Date:7/2/2015)... ... 2015 , ... Many Fourth of July celebrations will include fireworks this summer, ... is sharing some tips to promote the proper use of fireworks. , According to ... room daily with fireworks-related injuries in the month surrounding the Fourth of July. Amica ...
(Date:7/2/2015)... ... July 02, 2015 , ... Get ready ... SIGVARIS PERFORMANCE SOCKS. Since the socks were first introduced, they have rapidly been ... popularity has inspired four new, fun shades including: blue, lime, pink and red. ...
Breaking Medicine News(10 mins):Health News:Attorney from William Mattar Leads Discussion on Bicycle Accidents 2Health News:Learn How to Take Selfies like Kendall Jenner 2Health News:sweetFrog Opens 18th Location in the Lone Star State 2Health News:6 Fireworks Safety Tips from Amica Insurance 2Health News:SIGVARIS is Sporting Four Brand New Colors in the Popular PERFORMANCE SOCK Product Line 2
... management technology, aggressive fever control may improve neurologic ... 25 The nation,s top-rated neurology programs cool ... with the non-invasive, safe and technologically advanced ... 80 percent, or 23 of the 30 top-ranked ...
... CompleteM.E. Healthcare Education Solution Streamlines Student Evaluations and Consolidates Scheduling ... ... BC (PRWEB) March 25, 2009 -- one45 Software, a leading ... subsidiary of Cytiva Software Inc. (CRX:TSX.V), announced today the selection ...
... Professional is less invasive than blood tests at detecting lead levels in ... ... Until now, determining a person,s lead exposure has been an invasive procedure ... Professional, a new saliva-based lead test that screens for lead ...
... of the Program in Clinical Effectiveness (PCE), which has ... 1986, have achieved significant success in receiving grant support ... funders, along with other accomplishments considered key to establishing ... a joint program of Brigham and Women,s Hospital ...
... Lifestyle, age and weight have all been considered as risk ... open access journal Breast Cancer Research has found ... three times the risk of developing an aggressive ,triple negative ... In the US, which has the highest rate of breast ...
... BioHorizons announces today that its 2009 Global Symposium ... May 2, at the Hilton Chicago. This educational ... dentistry, treatment planning, implant surface treatments, tissue regeneration ... the outstanding and diverse expertise of top dental ...
Cached Medicine News:Health News:Top Neurology Programs Control Fever with Arctic Sun Cooling Technology 2Health News:Top Neurology Programs Control Fever with Arctic Sun Cooling Technology 3Health News:Texas A&M Health Science Center College of Medicine Selects one45 Software's Healthcare Education Suite 2Health News:Texas A&M Health Science Center College of Medicine Selects one45 Software's Healthcare Education Suite 3Health News:Texas A&M Health Science Center College of Medicine Selects one45 Software's Healthcare Education Suite 4Health News:The First Oral Based Lead Test, LeadConfirm Professional, Makes Getting The Lead Out Easier 2Health News:The First Oral Based Lead Test, LeadConfirm Professional, Makes Getting The Lead Out Easier 3Health News:The First Oral Based Lead Test, LeadConfirm Professional, Makes Getting The Lead Out Easier 4Health News:Intensive summer program helps physicians build clinical research careers 2Health News:Intensive summer program helps physicians build clinical research careers 3Health News:BioHorizons Announces Its 2009 Global Symposium: Bringing Together Top Thought Leaders in the Dental Implant Industry to Provide Insight on Integrating Technology into the Continuum of Care 2
Sharp tipped scissors angled 135 from the shaft with a horizontal cutting action. For cutting in the plane parallel to the retina and cutting membranes adherent to the retinal surface (delamination)....
Sharp tipped illuminated scissors with a curvature of 12 mm to follow the contour of the retina. For cutting in the plane parallel to the retina, cutting membranes adherent to the retinal surface and...
Microscissors : Horizontal Scissors...
Sharp tipped scissors with a vertical cutting action. Rounded lower edge of scissors blade minimizes unintentional engagement of retina....
Medicine Products: