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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan Sheet” and Scrip.  Previously she worked as an editor for Mealey’s Litigation Reports (now part of Lexis-Nexis), writing about asbestos, toxic tort and fen-phen litigation.
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Samsung Bioepis Data Suggest Clinical Impact From Herceptin Product Quality Drift

Post hoc data from a long-term safety study of Samsung’s trastuzumab biosimilar and Genentech’s reference product suggest event-free survival rates differ based on a shift in one of Herceptin’s key quality attributes; Genentech said it proactively alerted health authorities when the shift was detected and the evidence does not indicate a clinical impact on patient outcomes.

Biologics Biosimilars

Biosimilars: US FDA Favors Quality Range Testing For Comparative Analytical Assessments

New draft guidance on statistical approaches eliminates previous recommendations on tiered ranking and statistical equivalence testing of product quality attributes, giving biosimilar sponsors more flexibility.

Biosimilars Drug Approval Standards

Cell Therapies: US FDA Asked To Clarify Development Standards For Early-Phase Trials

Academic institutions confused about agency standards are overly cautious in requiring early-phase studies be conducted under full GMPs, experts say; CBER Director Marks highlights regulatory flexibility but cautions that formal written guidance could be misused by those in stem cell industry.

Regenerative Medicine Clinical Trials

How Drug Effects Are Assessed In Renally Impaired Patients Could Be Headed For A Change

US FDA advisory committee finds merit in each of four industry-suggested alternative approaches to the current paradigm for assessing the impact of renal impairment on drug exposures; agency's own 2010 draft guidance does not reflect its current thinking on the design of dedicated pharmacokinetic studies.

 

Advisory Committees Clinical Trials

Best Pathway To Interchangeable Insulins Is In The Eye Of The Beholder

Approaches suggested at a US FDA public hearing include allowing follow-on insulins to take a direct route to interchangeability without first having to be approved as biosimilars, and automatically declaring biosimilar insulins interchangeable with one or more reference products.

Biosimilars Biologics

Interchangeable Insulins Could Be Left Out Of Diabetes Treatment ‘Ecosystem’

US FDA assessment of proposed biosimilar and interchangeable insulins in existing delivery forms should be separate from a future determination of whether the products can be safely used as part of a digitally connected treatment system, Lilly says. FDA, AAM representatives suggest this ecosystem approach could become a barrier to access for follow-on products.

Biosimilars Biologics
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