Microbix Biosystems will participate in a four-member FDA-sponsored panel to address issues of comparability and equivalence at the 6th WCBP Symposium in Washington
Ken Hughes, vice president of scientific affairs for Microbix, will present to the forum at the WCBP 6th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products, on behalf of the company in a panel session to address key issues affecting FDA approval of generic biologics. The forum will take place today at the Renaissance Mayflower Hotel in Washington DC.
He is to be joined by three other panelists from the US Food and Drug Administration (FDA) and US pharma in the session.
Those panelists are from CDER(FDA), CBER (FDA), and Genentech.
"Microbix is recognised in the industry as one of the leading developers of multi-source biotherapeutics and accordingly was invited to present a case for generic biologics," explained Dr Hughes.
"Our involvement in generic protein drug development, with our urokinase products and biotherapeutics pipeline, means we have some valuable insight into the area of characterisation for comparable biologics," he said.
"This panel discussion will clarify distinctions and similarities between therapeutic equivalence and comparability and discuss how these differences apply to historical examples," he continued.
The WCBP (Well Characterized Biotechnology Pharmaceuticals) conference is co-sponsored by the FDA and organised by the California Separation Science Society (CaSSS), a not-for-profit medical group.
The meeting is attended by FDA regulators and leaders in the biopharmaceutical industry.
Microbix specialises in developing and manufacturing tissue culture-derived biologicals for an emerging world market for biotherapeutic drugs and vaccines.
It makes reagents for building diagnostic products and tools used in biotechnology research.
The company has expertise in advanced culture, purification and process validation technologies.
Its objective during the next decade is to become a major force in what is expected to be a multi-billion generic biotherapeutics market in North America.
