Celltrion Healthcare 102 weeks with Remsima(non-HCP)

1. ARE LESS EXPENSIVE ‘BIOSIMILAR’ DRUGS
AS EFFECTIVE AND SAFE AS ORIGINAL DRUGS
FOR TREATING AUTOIMMUNE DISEASES?
NEW RESULTS FROM THE ‘PLANETAS’ AND ‘PLANETRA’ CLINICAL TRIALS
Diseases caused by disorders in a patient’s immune
system – often called‘autoimmune diseases’– can be
severely debilitating. However, improvements have
been seen over the last two decades following the
discovery of drugs called ‘biologics’. Biologics act on
the immune system to reduce inflammation and pre-
vent the damage to cells that causes the debilitating
symptoms of these diseases. Unfortunately, because
they are more complicated to make compared with
other types of drugs, biologics tend to be very ex-
pensive. Consequently, this often means that many
patients who could benefit from biologics do not re-
ceive them. As a result, considerable effort has been
made to develop new types of drugs which are simi-
lar to biologics. Many of these new drugs – known as
‘biosimilars’ – are currently being tested in clinical tri-
als to ensure that they are safe, and that they work as
well as the original biologics.
Remsima®, known as infliximab-dyyb in the USA
and also by another brand name Inflectra®, is a
biosimilar of a biologic drug called infliximab (brand
name: Remicade®). Both Remsima® and reference
infliximab are antibodies that block the inflamma-
tion caused by a protein in the body called tumour
necrosis factor. Two large clinical trials, PLANETAS and
PLANETRA, have shown that in patients with the au-
toimmune diseases rheumatoid arthritis and ankylos-
ing spondylitis, Remsima® works as well as reference
infliximab and is just as safe. Largely based on this
evidence, Remsima® was approved by the European
Medicines Agency and the U. S. Food and Drug Ad-
ministration for treating all disorders that reference
infliximab was approved to treat, including rheuma-
toid arthritis, ankylosing spondylitis, psoriasis, and
inflammatory bowel diseases.
Findings from extension studies of the PLANETAS
and PLANETRA trials have recently been published.1,2
During the extension studies, patients already re-
ceiving Remsima® continued treatment, receiving
a total of 102 weeks of Remsima®. Patients who had
received reference infliximab switched to Remsima®
for 12 months. These studies showed that switching
weeks with
A clear reflection
of innovation, accessibility,
and efficacy
A clear reflection of what has been added to the treatment paradigm.
Evidence based switching,
Evidence supports biosimilar infliximab, Remsima.

2. to Remsima® after a year of treatment with reference
infliximab had no negative effect on the effective-
ness or safety of treatment. Furthermore, Remsima®
remained effective, with no unexpected safety issues,
when patients were treated for up to two years. Com-
pared with continued Remsima®, switching from ref-
erence infliximab to Remsima® had no effect on the
proportion of responders in patients with rheumatoid
arthritis or ankylosing spondylitis (Figure 1). Further-
more, in these patients, treatment with Remsima®
was as effective after two years as it was after one year
(Figure 2).
In conclusion, it is safe and effective for patients
with rheumatoid arthritis or ankylosing spondylitis to
switch drugs from reference infliximab to Remsima®.
Furthermore, long-term treatment with Remsima®
is just as safe and effective as short-term treatment
with this biosimilar. Given that Remsima® and other
biosimilars are expected to be less expensive than
original biologics, approval of these drugs is likely to
increase the number of patients able to benefit from
effective treatment for several debilitating autoim-
mune diseases.
Figure 1. Patients who switched from reference infliximab to
Remsima® continued to respond to treatment.1,2
Figure 2. Treatment with Remsima® remained effective for
long-term treatment (2 years).1,2
Rheumatoid
arthritis
patients
Ankylosing
spondylitis
patients
Rheumatoid
arthritis
patients
Ankylosing
spondylitis
patients
Patientsrespondingtotreatment(%)
100
80
60
40
20
0
Continuedtreatment
withRemsima®
Switchedfromreferenceinfliximab
toRemsima®
Continuedtreatment
withRemsima®
Switchedfromreferenceinfliximab
toRemsima®
74.1% 80.7%77.1% 76.9%
TreatmentwithRemsima®
for54weeks(1year)
TreatmentwithRemsima®
for102weeks(2years)
TreatmentwithRemsima®
for54weeks(1year)
TreatmentwithRemsima®
for102weeks(2years)
Patientsrespondingtotreatment(%)
100
80
60
40
20
0
74.7% 70.5%74.1% 80.7%
weeks with
1) Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13
(biosimilar infliximab) in patients with rheumatoid arthritis: comparison
between switching from reference infliximab to CT-P13 and continuing
CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2016; Epub
ahead of print.
2) Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from
reference infliximab to CT-P13 compared with maintenance of CT-P13
in ankylosing spondylitis: 102-week data from the PLANETAS extension
study. Ann Rheum Dis 2016; Epub ahead of print.
HCREM-02PB-0516
A clear reflection
of innovation, accessibility,
and efficacy
A clear reflection of what has been added to the treatment paradigm.
Evidence based switching,
Evidence supports biosimilar infliximab, Remsima.