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Biosimilars & Generics

Set Alert for Biosimilars & Generics

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.

Generic Drugs Intellectual Property

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.’

Intellectual Property Generic Drugs

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.

Generic Drugs Coronavirus COVID-19

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.

Australia Market Access

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.

Generic Drugs Legal Issues

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.

Biosimilars Drug Approval Standards

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.

User Fees Generic Drugs

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.

Coronavirus COVID-19 Drug Review

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.

Malaysia Singapore

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.

Biosimilars Review Pathway

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.

Intellectual Property Biosimilars

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.

Manufacturing FDA
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