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 The medicine, made by Novartis' generics arm Sandoz, was being
tested in patients with breast cancer undergoing chemotherapy, which
often knocks out their white blood cells, giving rise to a condition
known as neutropenia.
Results of the Phase III study also showed switching at each cycle
between the original drug, also known as filgrastim, and the
experimental copy had no impact on efficacy and safety, Novartis
said on Monday.
The data will be used to support Sandoz' application for approval of
a copycat filgrastim, which was accepted by U.S. regulators at the
end of July under a new pathway for so-called biosimilar drugs.
Sandoz is the world leader in cheaper copies of biotech medicines
known as biosimilars, which are expected to account for
approximately one quarter of the $100 billion worth of sales
stemming from off-patent biological drugs by the end of the decade.
The generics company already sells a biosimilar version of Amgen's
drug in more than 40 other countries, but the United States has been
slower than other markets to establish a regulatory framework for
biosimilars.
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Sandoz currently sells three biosimilars outside the United States
and has a further six molecules in late-stage development.
(Reporting by Caroline Copley, editing by Louise Heavens)
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