Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


One Year On, FDA Generic Drug Cluster Focuses On Facilitating Collaboration

Group Has Made Significant Progress Regarding Data Sharing

Executive Summary

Following its inaugural year, the FDA’s Generic Drug Cluster has formed data sharing arrangements concerning a number of vital indications.

You may also be interested in...

IGBA Supergroup Gets Audience With WTO

The CEO advisory committee established by the IGBA has held its inaugural meeting and begun discussions with the director-general of the World Trade Organization to promote the “essential role” of generics and biosimilars in global health, with the interaction described as a first step towards a continuing dialog.

IGBA Puts Together Global Leadership Alliance

Leaders from a host of the world’s top generics and biosimilars companies have come together as part of a CEO advisory committee put together by the IGBA. The committee is expected to provide a forum to share thinking on key issues affecting the off-patent industry and best position the industry on critical policy issues with a single collective voice.

FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?

Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.

Related Content


Latest News
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts