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February 9, 2012
Guidance on Biosimilars
If you're interested, here's the FDA's draft of their guidance on biosimilars, up on their site today. This is a slow-moving story that's going to end up having a big effect on the industry. Look at the number of top-selling drugs that are biologics, look at how long they're lasting on the market (patent protection or not), and you wonder how much competition will emerge, how successful it'll be, and how tricky it will be to approve things. If I were a real-time journalist, I'd mark this "Developing", but while that's true, in this case it means "Developing. . .over the next ten years".
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