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 The products from South Korean firm Celltrion and its partners
Hospira and Mundipharma will compete with Remicade, the original
branded drug from Johnson & Johnson and Merck & Co.
The potential of biosimilars to grab substantial business from
original brands was a key factor behind Pfizer’s decision this month
to buy Hospira for about $15 billion.
Unlisted Mundipharma said on Wednesday that it is launching its
biosimilar Remsima in Germany, Italy, Britain, the Netherlands,
Belgium and Luxembourg, following expiry of relevant Remicade
patents.
Hospira is to sell its product Inflectra in markets including
Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the
Netherlands, Spain and Sweden.
Copies of Remicade have been on sale for several months in some
smaller European markets, such as Norway, but the move into major
economies is a big step forward for products that could disrupt the
multibillion-dollar biotechnology industry.
Because biotech drugs are made from living cells it is impossible to
manufacture exact copies, as happens with simple chemical medicines,
so regulators have come up with the notion of approving products
that are similar enough to do the job.
Remicade, which has annual European sales of about 2 billion euros
($2.3 billion), and the two biosimilar copies all contain an
antibody known as infliximab.
There has been a fierce debate for many years on how rapidly
biosimilars will be adopted by doctors and the take-up of Remsima
and Inflectra in the likes of Germany, France and Britain will be an
important test.
Many more biosimilar copies of drugs for diseases ranging from
cancer to eye disorders are now in development, posing a threat to
leading biotech drugmakers such as Roche and AbbVie.
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Citigroup analyst Andrew Baum predicted this month that biosimilars
would result in at least $110 billion of value being transferred
from innovator companies to copycat producers between 2015 and 2025.
The upside for society is that they could generate an estimated $50
billion in savings for healthcare systems, Citi says.
Jorgen Jahnsen, professor of medicine and gastroenterology at the
University of Oslo, said that in Norway the use of biosimilar
infliximab had already enabled the healthcare system to make
considerable savings.
Another test for biosimilars is looming in the United States, where
a Food and Drug Administration advisory committee will decide on
March 17 whether to recommend Celltrion's biosimilar version of
Remicade.
($1 = 0.8797 euros)
(Editing by David Goodman)
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