Welcome!

News Feed Item

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

Ask Agency to require that biosimilars bear distinguishable names to enhance patient safety

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 www.janssen.com for more information.

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

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

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

 

 

SOURCE The Janssen Pharmaceutical Companies of Johnson & Johnson

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In his session at Cloud Expo, Alan Winters, an entertainment executive/TV producer turned serial entrepreneur, will present a success story of an entrepreneur who has both suffered through and benefited from offshore development across multiple businesses: The smart choice, or how to select the right offshore development partner Warning signs, or how to minimize chances of making the wrong choice Collaboration, or how to establish the most effective work processes Budget control, or how to max...
Imagine having the ability to leverage all of your current technology and to be able to compose it into one resource pool. Now imagine, as your business grows, not having to deploy a complete new appliance to scale your infrastructure. Also imagine a true multi-cloud capability that allows live migration without any modification between cloud environments regardless of whether that cloud is your private cloud or your public AWS, Azure or Google instance. Now think of a world that is not locked i...
SYS-CON Events announced today that Auditwerx will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Auditwerx specializes in SOC 1, SOC 2, and SOC 3 attestation services throughout the U.S. and Canada. As a division of Carr, Riggs & Ingram (CRI), one of the top 20 largest CPA firms nationally, you can expect the resources, skills, and experience of a much larger firm combined with the accessibility and attent...
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), will provide an overview of various initiatives to certifiy the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldw...
In his General Session at 16th Cloud Expo, David Shacochis, host of The Hybrid IT Files podcast and Vice President at CenturyLink, investigated three key trends of the “gigabit economy" though the story of a Fortune 500 communications company in transformation. Narrating how multi-modal hybrid IT, service automation, and agile delivery all intersect, he will cover the role of storytelling and empathy in achieving strategic alignment between the enterprise and its information technology.
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists discussed how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations might...
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem" ...
In his session at 20th Cloud Expo, Scott Davis, CTO of Embotics, will discuss how automation can provide the dynamic management required to cost-effectively deliver microservices and container solutions at scale. He will discuss how flexible automation is the key to effectively bridging and seamlessly coordinating both IT and developer needs for component orchestration across disparate clouds – an increasingly important requirement at today’s multi-cloud enterprise.
The essence of cloud computing is that all consumable IT resources are delivered as services. In his session at 15th Cloud Expo, Yung Chou, Technology Evangelist at Microsoft, demonstrated the concepts and implementations of two important cloud computing deliveries: Infrastructure as a Service (IaaS) and Platform as a Service (PaaS). He discussed from business and technical viewpoints what exactly they are, why we care, how they are different and in what ways, and the strategies for IT to transi...
The Internet of Things is clearly many things: data collection and analytics, wearables, Smart Grids and Smart Cities, the Industrial Internet, and more. Cool platforms like Arduino, Raspberry Pi, Intel's Galileo and Edison, and a diverse world of sensors are making the IoT a great toy box for developers in all these areas. In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists discussed what things are the most important, which will have the most profound e...
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
Niagara Networks exhibited at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.