Regulation

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?

New ICH draft guidance says a fed study is not necessary for most immediate-release solid oral dosage products and the FDA indicates it will consider revising product-specific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

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.

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.

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.

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.

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.

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

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.