The difficult manufacturing process for follow-on biologics may discourage companies
This article was originally published in The Gold Sheet
Doug Long, vice president of industry relations for IMS Health, made this prediction at a recent policy meeting sponsored by the Generic Pharmaceutical Association in Washington. Long asserted that while the EU currently has a regulatory approval system for follow-on biologics and will be ahead of the U.S. in developing these products, "U.S. manufacturers will not be far behind." And two key House health legislators, reps. Frank Pallone, D-N.J., and Henry Waxman, D-Calif., asserted at the meeting that Congress will enact an approval pathway for generic biologics this year
You may also be interested in...
Device Week, 05 March - Remote Monitoring Reimbursement, T-cell Diagnostics And A Digital Health Feature
In this week's podcast, managing editor Marion Webb discusses a new monthly digital health roundup which will soon feature on Medtech Insight. Managing editor Reed Miller discusses reimbursement difficulties as it applies to remote cardiac monitoring. UK-based reporter Barnaby Pickering gives an overview of an interview with the chief medical officer of Adaptive Biotechnologies about its new T-Detect platform.
Coronavirus Notebook: Italy Makes First Use Of EU’s Vaccine Export Control System, More Regulators Issue Guidance On Variants
Ukraine has established a system for issuing emergency use authorizations for COVID-19 vaccines that recognizes authorizations granted by other world regulators.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.