About this Author
DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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February 9, 2012

Guidance on Biosimilars

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Posted by Derek

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".

Comments (5) + TrackBacks (0) | Category: Regulatory Affairs


1. MPH on February 9, 2012 12:31 PM writes...

sorry for highjacking...speaking of biotech companies,
I'm looking for a summer intern in synthetic organic chemistry. If you are in your second, third, or fourth year of undergrad, send me your CV and research summary (what you have done before). It's at a major pharmaceutical company in San Francisco bay area.
MPHchemistry - at - gmail - dot - com

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2. Darwinsdog on February 9, 2012 3:12 PM writes...

The guidance avoids the standards for biosimilarity determination besides some 'vanilla' comments about protein sequence as relates to drug class. Beside issues of protein folding and post-translational modifications the requirements related to analytical impurities and identity determination are going to be the key to similarity assessment. Suppose the plan is to litigate this case-by-case and will hopefully be approached very cautiously by the regulatory agencies here and abroad.

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3. PPedroso on February 10, 2012 6:58 AM writes...

It seems that Case Western Reserve University is solving all the humanity's problems.

First was the Andrulis paper with the solution for the origin of Life.

And now is a major breaktrhough (this one seems more scientifically sound) in the Alzheimer Field, with some impressive results in an animal tg model:

The main author and the group behind this are from the Case Western Reserve University!

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4. petros on February 10, 2012 7:46 AM writes...

This is going to be a long drawn out process.

Epogen and, it has just become apparent, Enbrel have benefited from the existence of submarine patents filed under the old law, which provides long delays for companies trying to launch similar products because of the complex process issues. Look how Roche has been unable to get round Amgen's patents to permit a US launch of Mircera.

The producers of other biosimilars are likely to face many problems cirumventing biotech patents

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5. cell sam on February 10, 2012 11:35 PM writes...

For anyone considering that the FDA Biosimilars draft guidance does not enable generics, make yourself aware of what is required of a "patent-holding" manufacturer making changes in the manufacturing process. The requirements are more than some advocates feel is fair to require of a 'biosimilar' manufacturer. For some of us having experience with process change, we see that with this guidance the FDA is reserving the capacity to require the same control, safety and efficacy data that the label drug must provide with process changes. It is fair to say that the process is a major component of a successful biologic. And there is no single technology that can capture all the critical features of these complex molecule drugs.

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