Quality/GMPs

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Biocon Biologics Scores EC Approval for Biosimilar to Ustekinumab

February 24th 2025

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

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FDA Approves Bavarian Nordic’s Chikungunya Vaccine

By Patrick Lavery

February 19th 2025

Two Samsung Bioepis Biosimilars Approved by Both FDA and EC

By Patrick Lavery

February 19th 2025

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Astellas’ IZERVAY Gets FDA Approval for Expanded Label to Treat Geographic Atrophy

By Feliza Mirasol

February 19th 2025

FDA Approves GSK’s 5-in-1 Meningococcal Vaccine for Patients Aged 10 Through 25

By Patrick Lavery

February 19th 2025

Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

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More News

Pieces of the Inspection Puzzle: The Magnitude and Scope of Behind-the-Scenes Activities During an Inspection

Barbara Unger

July 1st 2003

A successful outcome to an FDA inspection is the fruit of planning, preparing, and training. Cultivate confident employees who are appropriately coached and clear about their responsibilities.

Inside Washington: Debate Escalates Over Follow-On Biologics

Jill Wechsler

July 1st 2003

FDA efforts to encourage generic drug approvals and to consolidate oversight for biotech therapies could open the door to biotech equivalents

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