Generics Bulletin Editor’s Picks For Q2 2022
Highlights Across The Off-Patent Sector From April To June 2022
Looking back over the second quarter of 2022, Generics Bulletin executive editor Dave Wallace picks out highlights from April to June that include multiple first generic and biosimilar launches, some noteworthy executive moves, further preparation for biosimilar competition to Humira in the US, and a major European industry conference.
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Sandoz’s High-Concentration Humira Biosimilar Lands On FDA’s Desk
Sandoz has named its three most promising upcoming biosimilar launches, ahead of filing its proposed high-concentration version of adalimumab with the US Food and Drug Administration.
EU Health Emergency Response Authority Calls On Off-Patent Sector
The director-general of the European Commission’s recently-formed Health Emergency Response Authority addressed delegates to off-patent association Medicines for Europe’s 2022 annual conference, noting that it was preparing a report for post-summer as the HERA assessed its priorities.
EMA Firms Up February 2025 Date For Shortages Monitoring Platform
During the recent Medicines for Europe 2022 annual conference, held in Sitges, Barcelona, the EMA’s head of supply and availability of medicines and devices, Monica Dias, provided delegates with a detailed update on plans to implement the agency’s major shortages monitoring platform by early 2025.