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FDA Publishes Raft Of Guidances To Promote Competition

Documents Cover ANDA Submissions, Labeling Updates And Information Requests

Executive Summary

The US FDA has published a raft of guidances on ANDA submissions and labeling updates as well as information requests and discipline review letters.

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UK Lucentis Biosimilar Nod Offers Teva Potential First-Mover Advantage

Teva is gearing up to introduce the Ongavia ranibizumab biosimilar in the UK, following an approval by the local regulator ahead of its European counterpart. The development means the Israeli firm and partners Bioeq and Formycon could secure a global first launch of a rival to Lucentis, ahead of expected imminent launches by Samsung Bioepis of its Byooviz version in the US and Europe.

IFC And Nippon Chemiphar Ally In Asia, Middle East And Africa

Japan’s Nippon Chemiphar and the International Finance Corporation have announced an alliance that will see the pair collaborate to boost local production of generics in Asia, the Middle East and Africa, as part of efforts to reduce reliance on imports.

Burton Takes Lead At AAM’s Biosimilars Council

Craig Burton is stepping up to become executive director of the US Association for Accessible Medicines’ Biosimilars Council, as Christine Simmon has moved on to become president and CEO of the Food and Drug Law Institute. At the same time, Burton has added oversight of strategic alliances to his existing policy role with the AAM.

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