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Set Alert for Regulation

Is It Time To Promote US FDA’s Biosimilars Office Out Of OND?

Making the Office of Therapeutic Biologics and Biosimilars a stand-alone office in CDER may allow it to add more expertise, but is there an appetite for another reorganization?

Biosimilars FDA

Is US FDA Preparing to Remove Some Fed Study Requirements For Generic Bioequivalence?

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific guidances to harmonize standards.

Generic Drugs Clinical Trials

Medicines For Europe Highlights Industry Agenda

Ahead of its annual meeting in Malta in mid-June, European off-patent industry association Medicines for Europe has set out the hot topics for generics and biosimilars stakeholders that delegates will be looking to discuss.

Europe Legislation

US FDA Doesn’t Want ANDAs With Facilities Not Ready For Inspection Even Though It Can Accept Them

An agency official said the GDUFA III provision hopefully will be used for only a small number of ANDAs. We chart the approval times and first-cycle clearances over the course of the generic user fee program.

Generic Drugs Manufacturing

European Industry Voices Concern As Products Vanish From Market

A fresh report has offered stark new data on the extent to which generics are disappearing from the European market. Industry association Medicines for Europe has pointed to the risks of supply consolidation, urging both national- and EU-level action.

Generic Drugs Supply Chain

IGBA Offers Input On WHO Pandemic Accord

As the WHO seeks input on a global accord to strengthen pandemic preparedness, the IGBA has provided suggestions from the off-patent industry ahead of a key step in the drafting process later this month.

Supply Chain International

Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars

Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.

Biosimilars Clinical Trials

Celltrion Enters Race For Ocrevus Biosimilar, Files Omalizumab In Europe

Celltrion is keeping both eyes firmly on the future as it begins clinical trials for one biosimilar and files another in Europe.

Biosimilars Clinical Trials

EU Reforms Offer Mixed Blessings For Generics And Biosimilars

A long-awaited package of European pharmaceutical legislation reforms unveiled by the European Commission contains a number of measures relating to generics and biosimilars – including changes to regulatory data protection periods, simplified marketing authorization procedures and moves towards greater digitalization.

Regulation Europe
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