[SP0026]
J. Goncalves
and colleagues were asking: "IN SEARCH FOR MAB BIOSIMILARITY: HOW TO OVERCOME
OBSTACLES?" "The guidelines (of the European Medicines Agency
(EMEA)) advocate pre-clinical and clinical testing of biosimilars prior to
market authorization, complemented by tailored pharmacovigilance plans. These
guidelines provide a valuable base from which to develop in this evolving
regulatory environment."
[SP0119]
J. Braun taked on:
"LATEST UPDATE ON BIOSIMILARS - CHANCES AND RISKS". "EMA and FDA
regulations as well as scientific considerations indicate that biosimilarity
does not imply interchangeability. In Rheumatology the first biosimilar has
recently been approved in Europe – a biosimilar
to infliximab which has passed all tests and examens and that is produced by a
Korean company." It's Remsima by Celltrion.
[OP0011]
S.-C. Bae and
colleagues presented: "A RANDOMIZED, DOUBLE-BLIND, PHASE 3 EQUIVALENCE
TRIAL COMPARING THE ETANERCEPT BIOSIMILAR, HD203, WITH ENBRELR, IN
COMBINATION WITH METHOTREXATE (MTX) IN PATIENTS WITH RHEUMATOID ARTHRITIS
(RA)". HD203 is a biosimilar of etanercept. Conclusions:
"The study met the primary endpoint of demonstrating equivalence in efficacy
of HD203 compared with EnbrelR. HD203 was well tolerated, with a safety
profile comparable to that of EnbrelR in this population of Korean patients with
RA." HD203 is produced by South Korean Hanwha Chemical.
[OP0012]
J. Kay and colleagues presented: "A PHASE 3,
RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR STUDY OF THE EFFICACY AND SAFETY OF
BOW015, A BIOSIMILAR INFLIXIMAB, IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS
ON STABLE METHOTREXATE DOSES". Conclusions: "This is the
first clinical trial of a biosimilar IFX to demonstrate and report the kinetics
of response to treatment prior to the plateau phase. The comparable proportion
of responders at each of these early time points and at the Wk 16 primary
endpoint provides convincing evidence of therapeutic equivalence." So
there's another infliximab biosimilar at the horizon, produced by Epirus
Biopharmaceuticals, Inc.
There have been updates on the PLANETRA study
(infliximab biosimilar).
[FRI0264]
P. Kaur
presented the following study: "A RANDOMIZED, SINGLE-BLIND, SINGLE-DOSE, THREE-ARM,
PARALLEL GROUP STUDY IN HEALTHY SUBJECTS TO DEMONSTRATE PHARMACOKINETIC
EQUIVALENCE OF ABP 501 AND ADALIMUMAB: RESULTS OF COMPARISON WITH ADALIMUMAB
(EU)". Conclusions: "Results of this phase 1 study demonstrated
bioequivalence of ABP 501 following a single 40-mg SC injection relative to
that from a 40-mg SC injection of adalimumab (EU). No new safety signals with
ABP 501 treatment were identified."
[FRI0301]
C. Udata and
colleagues presented: "A PHASE I PHARMACOKINETICS TRIAL COMPARING
PF-06438179 (A POTENTIAL BIOSIMILAR) AND INFLIXIMAB IN HEALTHY VOLUNTEERS
(REFLECTIONS B537-01)". Conclusions: "This study
demonstrates PK similarity of PF-06438179 to both infliximab-US and
infliximab-EU and of infliximab-EU to infliximab-US. The 3 study drugs were generally
safe and well-tolerated in this study." What, if Remicade will be
available at a price level of Denusomab? But this study is phase 1!
[FRI0309]
D. Yin and
colleagues presented: "A PHASE I PHARMACOKINETICS TRIAL COMPARING
PF-05280586 (A POTENTIAL BIOSIMILAR) AND RITUXIMAB IN SUBJECTS WITH ACTIVE
RHEUMATOID ARTHRITIS WITH ACTIVE DISEASE IN TNF FAILURES (REFLECTIONS
B328-01)". Conclusions: "This study demonstrates PK similarity of
PF-05280586 to both rituximab-US and rituximab-EU and rituximab-EU to
rituximab-US. All 3 treatments were generally well tolerated, with a low
incidence of treatment-related AEs and discontinuations due to AEs."
[SAT0094]
S. Narayanan:
"RELATIONSHIP BETWEEN THE DURATION OF RHEUMATOLOGY PRACTICE EXPERIENCE AND
LIKELIHOOD OF USE AND PERCEPTION TOWARDS BIOSIMILARS IN RHEUMATOID ARTHRITIS
ARENA". Conclusions: "Rheumatologists perceptions varied based on
their practiceexperience; among those with ≤10yrs of practice-experience, higher proportion stated being doubtful or
less/not likely of prescribing biosimilars to eligible RA patients, and a
higher proportion of them cited national treatment guidelines and lack of data
from local country/market among key reasons preventing biosimilar use.
Conversely, among those with >20yrs of practice experience, a lower
proportion cited lack of treatment guidelines and lack of data from local
country/market as key reasons preventing biosimilar use." Doesn't this look
grim for the producers of biosimilars?
[AB0412]
U. Kronthaler
and colleagues presented: "PRECLINICAL PK AND SAFETY ASSESSMENT OF THE
PROPOSED ADALIMUMAB BIOSIMILAR GP2017, COMPARED TO HUMIRAR". The study has been done in rabbits and in
cynomolgus monkeys. Conclusions: "Pre-clinical
pharmacokinetic studies are a sensitive means to characterize proposed
biosimilars compared to their reference product. Similar AUC and Cmax of GP2017 and
HumiraR are shown here in two species, upon single or repeated s.c. administration.
..." Sandoz Biopharmaceuticals, Hexal AG also want a piece
of the pie.
[AB1052]
F. Berghea and
colleagues looked at: "BIOSIMILARS USE IN RHEUMATOLOGY - THE PATIENT
PERSPECTIVE". Conclusions: "In few areas (but not everywhere) the patient’s knowledge about drug (copies) might be deeper than we expect; the
socio-economic advantages of biosimilars seems to be fully understood; treating
physician should made the choice and assume the responsibilities; in the
absence of financial constrictions the idea of a free switch between originals
an biosimilars doesn’t seem to have
many adepts. The study reveals a great need for education and debate in this
area in order to fully accommodate the concept of biosimilars in rheumatic
patients."
There seems to be a lot going on, but Remsima hasn't
knocked on my door, yet.
Links:
Biosimilars at the 2013 EULAR Meeting in Madrid http://rheumatologe.blogspot.de/2013/07/biosimilars-after-eular-2013.html
Biosimilars at the 2013 ACR Meeting in San Diego
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