NEWARK, Del.--(BUSINESS WIRE)-- Terence E. Ryan, PhD, senior vice president of iBio, Inc. (OTCBB: IBPM), yesterday described the importance of improved manufacturing technologies for biosimilars to achieve the objectives of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), at the two-day open hearing “Approval Pathway for Biosimilar and Interchangeable Biological Products” held on the U.S. Food and Drug Administration’s White Oak Campus in Silver Spring, Maryland.
The focus of Dr. Ryan’s statement was the importance of making the benefits of biologics available to broader populations through the use of new, efficient manufacturing technologies. Dr. Ryan recommended that clinical trials be required only when necessary in exceptional cases, and not as a general means of delaying adoption of beneficial new technologies. “Virtually all existing biotherapeutics can be manufactured to the highest clinical standards at substantially reduced costs with our iBioLaunch™ whole green plant technology,” said Dr. Ryan. “Public health is best served by products that are both safe and effective, and also readily accessible, a combination of objectives delivered with our technologies.”
iBio was one of forty-six presenters at the two-day hearing. Pharmaceutical companies presenting included Amgen, Inc.; Novartis; Watson Pharmaceuticals; Pfizer, Inc.; Merck and Co., and Genentech.
The FDA scheduled this hearing “to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009.” The purpose of this public hearing was to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute. FDA will take the information it obtains from the public hearing into account in its implementation of the BPCI Act.
For a complete transcript of yesterday’s iBio presentation, please visit: www.ibioinc.com/news
About iBio, Inc.
iBio, Inc. (OTCBB: IBPM) is a biotech company commercializing its proprietary, transformative iBioLaunch™ technology platform for the production of biologics including therapeutic proteins and vaccines. The iBioLaunch platform uses transient gene expression in plants for superior efficiency in protein production. Advantages include significantly lower capital and process costs, and the technology is ideally suited to infectious disease applications where speed, scalability, and surge capacity are important. iBio owns the IP/technology developed at the not-for-profit Fraunhofer USA Center for Molecular Biotechnology, and continues to sponsor development and refinement of the technology for broad applications in human healthcare. Further information is available at www.ibioinc.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995:
Statements included in this release related to iBio, Inc. may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as competitive factors, technological development, market demand, and the Company's ability to obtain new contracts and accurately estimate net revenues due to variability in size, scope and duration of projects. Further information on potential risk factors that could affect the Company's financial results can be found in the company's Reports filed with the Securities and Exchange Commission.
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical Research FDA Science