Biosimilars & Generics
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Generic Drugs: ‘Competitive’ Exclusivity Benefited Few Sponsors But Is Increasingly Popular
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.
US FDA’s Patent ‘Concerns’ Include Thickets, Product Hopping, And Evergreening
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.’
ANDA Guidance Says Yes To Limited Stability Data, No To Expired Reference Product During COVID
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.
Australian Industry Signs Deal To Fund Access To Innovative New Drugs
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.
Amicus' Acquiescence To Teva’s Drug Supply Request Reflects Power Of CREATES Act
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.
GDUFA III Talks Completed; Fees will Fund Inspection, Complex Generic Improvements
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
COVID-19 Supplement Approvals Jump, Some On-Time Decision Rates Slip For US FDA
In FY '21 third quarter, on-time decision rate improved for generics and biosimilars, but dropped again for new drug applications.
Malaysia, Singapore Join Hands On Review Of Generic Drugs
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.
International Regulators Explain Work-Sharing Scheme For Biosimilars
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.
Patent Thickets And Legislative Logjams
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.
FDA Inspection Vista Amid COVID-19, How Things Are Poised For Indian Firms
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.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.