LONDON, Sept 10 The European Commission has
approved the first copycat version of an antibody-based drug,
clearing the way for increased competition for the makers of
multi-billion dollar biotechnology drugs to treat complex
Tuesday's final green light for Inflectra - which was
developed by South Korea's Celltrion and will be
marketed by U.S. company Hospira - had been expected
following a European Medicines Agency recommendation in June.
Hospira said the drug for treating rheumatoid arthritis and
some other conditions would be launched throughout Europe "at
the earliest opportunity taking into account any relevant patent
Inflectra is a so-called biosimilar version of Johnson &
Johnson and Merck & Co's Remicade.
Unlike traditional chemical drugs, biotech medicines consist
of proteins derived from living organisms that cannot be
replicated exactly. Biosimilars, therefore, are more difficult
to develop and need more tests to prove they work properly.
Until now biotech medicines like Remicade, given by
injection or infusion, have been largely immune from generic
competition, unlike conventional pills.
But Europe's approval of the Celltrion/Hospira product shows
the changing landscape as regulators set out a clearer path for
the evidence needed to secure approval of such drugs.
Celltrion said in June it was planning to seek approval in
Japan later this year and that an application for U.S. approval
is possible in 2015.