Celltrion taps Oracle Health Sciences Safety Solutions to Help Bring Cost-Effective Life-Saving and Biosimilar Drugs to Market

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Driven by the cost saving potential of biosimilar drugs – an estimated $100 Billion in global healthcare spending cuts by the end of 2020* – there is an emergence of biosimilar drug manufacturers entering the market and regulatory bodies like the FDA are helping to accelerate getting these drugs to market. A key aspect in getting these treatments to market is safety and efficacy regulatory reporting, and Celltrion has turned to Oracle Health Sciences technology to help streamline the process.

"Since our founding in 2002, we have remained committed to making more advanced therapeutics available to everyone, and have turned to technology to help us achieve our goals. Oracle Health Sciences technology is supporting us in meeting today's regulatory requirements and will enable us to move and shift as the regulatory landscape evolves, so that we can bring more life-saving and treatments to market safely and cost-effectively," said Dr. Sang Joon Lee, vice president for Celltrion, Inc.  

In an effort to streamline its pharmacovigilance case management and reduce IT costs, Celltrion has selected Oracle Health Sciences Argus Enterprise Edition which provides a comprehensive platform that will enable the company to make faster and better safety decisions, optimize global compliance and integrate risk management into key processes. Oracle Health Sciences Empirica Signal delivers a dynamic, visual data-mining environment that will enable Celltrion to detect safety signals, uncover patterns and recognize trends in spontaneous adverse event reporting.

"It is great to see the biopharmaceutical market headed in new and innovative directions as we are seeing with the emergence of more biosimilar manufacturers. Oracle Health Sciences remains committed to evolving and innovating to continue meeting the needs of our existing and potential customers," said Steve Rosenberg, general manager, Oracle Health Sciences. "Celltrion is a glowing example of a biotech company that is innovating to help improve people's lives."

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About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EMA approval for Inflectra® and Remsima®, respectively, which is the world's first mAb biosimilar to receive approval from a regulatory agency in a developed country. Celltrion also received EMA approval for Truxima™ (CT-P10, a proposed mAb biosimilar to Rituxan^® (Rituximab)) in February 2017. For more information, visit www.celltion.com.

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