What’s Next? Five Things To Look Out For In May
Pair Of Key Investor/Capital Market Days; Major EU Biosimilars Conference
Generics Bulletin previews the most notable and anticipated events for May 2023.
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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.
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 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.