Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Titanium dioxide is now officially banned as an ingredient in foods and dietary supplements in the European Union on safety grounds. However, manufacturers can still place products containing the chemical compound on the market for six months, and then any products still on the market can remain until their expiry date. Meanwhile, the European Commission and pharmaceutical companies have three years to find titanium dioxide alternatives for medicines, or justify why it should continue to be used.
Biocon anticipates significant US uptake of its Viatris-partnered interchangeable insulin glargine biosimilar on the back of commercial arrangements in place and expects to "move the market" in 2022. All eyes are also on the trajectory of biosimilar insulin aspart, which received a CRL from the US FDA.
To extend its representation in Europe, IGBA has welcomed the generic and biosimilar drug association of Serbia and Montenegro – Genezis – to the global off-patent industry body.