Navigation Links
Janssen Pharmaceutical Companies of Johnson & Johnson Submit Citizen Petition to the U.S. FDA Regarding Naming of Biosimilars

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 distinguish it from other similar products and ensure effective pharmacovigilance.  Additionally, some biosimilars will likely not be approved for all approved uses of the reference product so shared names will increase the probability that patients are treated with a drug that is neither approved nor scientifically demonstrated to be safe and effective for the intended use.

"Our own experience with EPREX®/ERYPO® (epoetin alfa) has informed our views and highlights important considerations concerning the naming of biosimilars," said Dr. Siegel.  "These considerations include the need for reliable pharmacovigilance mechanisms for detection and investigation of postmarketing safety signals, the importance of the ability to identify precisely which product a patient has received and the risks associated with inadvertent switching between products," he said.

"We have a long history of supporting efforts to establish an approval pathway for biosimilars that is in the best interest of patient safety," said Dr. Siegel.  "While we fully appreciate efforts to address the need to expand access to safe and affordable medicines – including therapeutic biologics - the standards and policies applied to biosimilars must place a high priority on assuring patient safety and welfare," he added.

About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people with serious diseases throughout the world.  Beyond its innovative medicines, Janssen is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.

Please visit for more information.

Mark T. Wolfe
Tel: (732) 524-5799
Mobile: (908) 672-4988

Johnson & Johnson
Louise Mehrotra
Tel: (732) 524-6491

Johnson & Johnson
Stan Panasewicz
Tel: (732) 524-2524



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

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:
(Date:6/23/2016)... Research and Markets has announced the addition ... Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, Binder, ... Forecast to 2021" report to their offering. ... excipients market is projected to reach USD 8.1 Billion ... forecast period 2016 to 2021. The ...
(Date:6/23/2016)... ANGELES , June 23, 2016 ... CAPR ), a biotechnology company focused ... therapeutics, today announced that patient enrollment in its ... in Duchenne) has exceeded 50% of its 24-patient ... enrollment in the third quarter of 2016, and ...
(Date:6/23/2016)... and INDIANAPOLIS , June 23, 2016 ... Lilly Diabetes Tomorrow,s Leaders Scholarship is any indication, the ... announced today online at by the ... diabetes stand in the way of academic and community ... Foundation,s scholarship program since 2012, and continues to advocate ...
Breaking Medicine Technology:
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
(Date:6/24/2016)... Norcross, Georgia (PRWEB) , ... June 24, 2016 ... ... Year” awards today at the Clinical Decision Making in Emergency Medicine conference in ... who have authored journal articles published in Emergency Medicine Practice and ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions today ... cultivation and processing operations at its production facility, and opened its first two ... the manufacturer of a complete system of proactive air and surface purification solutions ...
(Date:6/24/2016)... , ... June 24, 2016 , ... National recruitment firm ... life sciences executive with extensive sequencing and genomics experience, as Vice President of North ... Ms. Hill will be responsible for leading the sales team in the commercialization of ...
(Date:6/24/2016)... ... June 24, 2016 , ... Today, ... stem (iPS) cells and other difficult to transfect cells, announces its launch of ... PluriQ™ G9™ Gene Editing System is a complete system for culturing and ...
Breaking Medicine News(10 mins):