The Big Break for Biosimilars?
The first US biosimilar has been pocketed and the game is on. We bring six experts to the table to discuss the impact on industry dynamics.
Stephanie Sutton |
Back in April 2006, the first biosimilar in the European Union received marketing authorization – Omnitrope, developed by Sandoz as a biosimilar to Pfizer’s Genotropin (somatropin). At the time, there was no sign of a biosimilars pathway in the US, but everyone anticipated that such products would eventually jump the Atlantic. ‘Eventually’ was nearly nine years later when on March 6, 2015, the FDA officially approved the first US biosimilar – Zarxio (filgrastim-sndz) from Sandoz (1), which is approved for the same indications as Amgen’s Neupogen (filgrastim). Is the US biosimilars market now open for business and ready to start churning out a whole raft of new products? That really depends on who you speak to...
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