What’s Next? Five Things To Look Out For In May
Pair Of Key Investor/Capital Market Days; Major EU Biosimilars Conference
Executive Summary
Generics Bulletin previews the most notable and anticipated events for May 2023.
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Alvotech’s Latest FDA Knockback Cuts It Fine For Humira Rival
Alvotech has received a further complete response letter from the US FDA relating to its AVT02 proposed adalimumab biosimilar rival to Humira. The latest BsUFA goal date disclosed for the product is now just a few days ahead of a potential US launch.
For First US OTC Birth Control Application, FDA Extends Time For Advisory Panel Discussion
After postponing planned November advisory committees’ meeting to have time to review more information it requested from sponsor HRA Pharma, FDA sets meeting for 9-10 May. Expanding meeting from one day to a day and a half should allow considering all views and questions about contraceptives.
Sandoz Gains An Edge With High-Concentration US Humira Biosimilar
Sandoz has gained a potential advantage ahead of being part of a second wave of Humira biosimilar competition hitting the US, with the firm obtaining FDA approval for its Hyrimoz version of adalimumab in a citrate-free high-concentration formulation.