GBMA hails biosimilar tick
August 21, 2015
Hospira has announced that
Inflectra (infliximab), biosimilar to
Janssen-Cilag’s Remicade, has been
registered in Australia.
As the first monoclonal antibody
to be approved, the registration
potentially paves the way for the
government to reduce the cost
of some of the most costly drugs
on the PBS, with Remicade alone
coming in at around $100m a year.
Inflectra has been registered
in Australia for the treatment of
eight inflammatory conditions:
rheumatoid arthritis (RA); psoriatic
arthritis; ankylosing spondylitis
(AS); adult and paediatric Crohn’s
disease; refractory fistulising
Crohn’s disease; adult and
paediatric ulcerative colitis; and
plaque psoriasis.
The PBAC is also considering
a PBS listing for Inflectra, with a recommendation expected today.
The Generic and Biosimilar
Medicines Association (GBMA)
has welcomed the approval as a
landmark event for the biologicals
market presently worth $2.3b in
Australia equivalent to 25% of
annual PBS expenditure.
“The approval of biosimilar
infliximab is great news for patients
as it provides an additional
treatment option for those living
with some of the most debilitating
autoimmune diseases and will
create savings allowing greater
access to newer, more expensive
medicines,” said GBMA ceo Belinda
Wood.
“Importantly, the approval of
biosimilar infliximab increases the
TGA’s experience in appropriately
evaluating biosimilars, including
extrapolating indications from the
reference biological medicine.
“This is essential if Australia is
to unlock the full value offered by
biosimilars,” she added.
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