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 Biosimilars aim to copy biologic products, which are made inside
living cells, but they can never be exact duplicates, so biosimilar
manufacturers need to conduct clinical trials to show their products
work as intended.
Enbrel, or etanercept as the drug is known generically, is a big
prize since it was the world's fifth-biggest selling medicine in
2014 with sales of nearly $9 billion.
Amgen, which sells the drug in North America, booked Enbrel sales of
$4.7 billion last year. Pfizer <PFE.N> sells Enbrel elsewhere.
Merck <MRK.N> and Samsung Bioepis last month won approval for
biosimilar etanercept in South Korea and a copy is also on the way
in Europe, where Samsung [SAGR.UL] is working with Biogen <BIIB.O>,
but Sandoz said it believed it was the first company to receive a
U.S. FDA file acceptance.
Sandoz is seeking approval for all indications included in the label
for Enbrel, a so-called anti-TNF drug, which is used to treat a
range of autoimmune diseases including rheumatoid arthritis and
psoriasis, it said in a statement.
Novartis last month launched the first biosimilar drug in the United
States after a U.S. appeals court declined to stop the sale of the
company's copycat version of Amgen's blockbuster cancer drug
Neupogen.
Insurers and government healthcare systems hope biosimilars will
cost the public 40 percent to 50 percent less than the original
drugs and experience in Europe suggests that steep discounts are
being offered in some markets.
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"Sandoz believes that the totality of evidence in its submission,
including two pivotal clinical studies, will demonstrate that the
proposed biosimilar is essentially the same as the reference
product," Novartis said on Friday.
The potential for biosimilars to take a large slice of the market is
grabbing the attention of both healthcare providers, who see big
budget savings, and investors, worried about the impact on the
profits of companies making original products.
(Reporting by Michael Shields and Ben Hirschler; Editing by
Muralikumar Anantharaman ad Greg Mahlich)
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