Biosimilars & Generics
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The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.
Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’
US FDA's updated Q&A guidance on developing generics for submission via the abbreviated new drug application pathway during the COVID-19 pandemic has been published.
Hot on the heels of Australia’s plan to overhaul the National Medicines Policy comes a new deal with the pharmaceutical industry to make new drugs available as soon as possible after approval and get patients more closely involved in reimbursement processes.
Teva dismissed its suit against Amicus Therapeutics after the latter agreed to provide requested quantities of its Fabry disease treatment Galafold. The quick resolution of the complaint illustrates the success of the legislation in halting the drug supply dispute but leaves some unanswered questions.
Biosimilars: Deep Product Understanding Will Move Regulators To Reduce Clinical Data Requirements, US FDA Official Says
New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
In FY '21 third quarter, on-time decision rate improved for generics and biosimilars, but dropped again for new drug applications.
The National Pharmaceutical Regulatory Agency and the Health Sciences Authority have announced a pilot to kick-off their new initiative on the simultaneous assessment of new generic drugs.
New guidance from the ACCESS Consortium of regulators from five countries explains how biosimilar drug sponsors can apply for an internationally-coordinated review of new products.
US Senate hearing on pharmaceutical competition brought renewed interest to idea of pruning so-called ‘patent thickets.’ But the choking growth of legislative proposals may itself by hampering progress on Capitol Hill.
The US FDA conducted seven drug inspections in India from February through August 2021 and front-line Indian firms are hopeful things will pick up further and that some pre-approval inspections may happen virtually. But no foreign surveillance inspections are expected to be conducted by FDA inspectors traveling from the US before September 2021.
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