Thursday, August 12, 2010

Podcast: Mark McCamish, Sandoz, on the approval of a generic version of Lovenox

Recently, the U.S. Food and Drug Administration granted marketing approval of the Abbreviated New Drug Application (ANDA) for enoxaparin sodium for injection, a product that has been designated therapeutically equivalent to Lovenox®. While it is not protein-based, it is an extremely complicated molecule to make and refine - similar to attempting to reproduce a biologic.

We interviewed Mark McCamish, Head of Global Biopharmaceutical Development at Sandoz and Keynote Speaker at the 2nd Annual Business of Biosimilars event to get his expert industry perspective on the recent development.

Read the podcast transcript here:

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1 comment :

Unknown said...

Hi there, thanks for the interesting podcast! On the same issue we just had a blog, too: Why does the FDA authorisation of the first generic Lovenox, Enoxaparin Sodium Injection, cause so much interest these days?
Kind regards, Henriette

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