Article preview from The RPM Report June 23, 2009
Biosimilars haven't had a huge impact in Europe-yet. Sponsors and analysts expect that to change over time. Will the US market parallel the European experience? Read more...
Article preview from The RPM Report June 23, 2009
"You can be sure we're on a winning train, and [sales] will go up," says Hannes Teissl, head of Biopharmaceuticals at Sandoz, of the biosimilars situation in Europe. "The debate is over how long" it will take.
Novartis AG's Sandoz is a biosimilars leader, with three marketed drugs: Omnitrope (somatropin, human growth hormone), Binocrit (Epoetin alfa) and Zanzio (filgrastim).
Omnitrope was approved in the EU in 2006 and the same year in the US via the abbreviated 505 (b)(2) pathway—after legal wrangling with a reluctant FDA.
But the drug, despite being at least 25% cheaper than incumbents including Pfizer Inc.'s Genotropin or Merck Serono SA's Saizen, has hardly been a rip-roaring success. It sells less than $4 million per year in the US according to IMS Health—that's about 1% of the total growth hormone market. (European figures are difficult to compile because of different distribution systems and lack of transparency.) Nor has biosimilar growth hormone pushed up usage: the number of overall units sold has stayed relatively flat. "It's not impressive," summed up IMS Health's Alan Sheppard, Principal, Global Generics. "Omnitrope has failed to gain significant share" in the US.
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