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Two Months To Add Two Words – Biosimilar Supplement Review Times May Be Hindering Uptake

 
• By Derrick Gingery

Biosimilar supplement approvals by the US FDA take on average about five months as sponsors request easier and quicker ways to update labels.

FDA Approved typed words on a vintage typewriter
In a few cases, the innovator product had a supplement approved faster than the same filing from the biosimilar.

Simple updates to biosimilar labels are taking several months to receive US Food and Drug Administration approval, potentially affecting the growth of the fledgling sector.

Slow supplement approvals may not constitute a major problem at the moment, but as more biosimilars enter the market, the need to quickly change a label to stay in line with the reference product or add indications no

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