I’ve already written a longer text after the 2013 EULAR in
Madrid last year, please use the link below. At this time EMEA's Committee for
Medicinal Products for Human Use (CMHP) had recommended biosimilars of
infliximab by Celltrion and Hospira to be granted the same indications as
Remicade®. I haven’t seen any news on when biosimilars will be available in
Europe so far. So, the meetings are extremely important to look at the progress
of biosimilars.
At the ACR meeting there were only four publications
concerning biosimilars.
Rituximab Biosimilar
(CT-P10) by Celltrion:
Dae-Hyun
Yoo and colleagues, most working for Celltrion, presented the following study
[#1736]: “A Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group,
Double-Blind Study To Demonstrate The Equivalence Of CT-P10 To Innovator
Rituximab With Respect To Pharmacokinetic Profile In Patients With Rheumatoid
Arthritis.” Conclusion: „CT-P10 and RTX were equivalent in terms of AUC0–last
and Cmax in patients with active RA. Clinical efficacy for ACR20/50/70
and EULAR response rates and PD for B-cell kinetics were comparable between the
two treatment groups. CT-P10
was well tolerated with a safety profile comparable to that of RTX up to week
24.“
Etanercept Biosimilar
(GP2015) by Novartis:
A. da Silva
and colleagues, most working for Novartis, presented this study [#1862]:
“Target-Directed Development Of a Proposed Biosimilar Etanercept, GP2015:
Comparability Of In Vitro Target Binding and Pre-Clinical Efficacy and
Pharmacokinetics.” Conclusion: “This non-clinical similarity exercise confirms
that GP2015 and the reference medicinal product are pharmacologically
highly-similar with regard to target binding, anti-TNF_ biological activity and
PK exposure. Future clinical trial(s) are needed to provide evidence of
similar efficacy and safety of GP2015 to that of the originator product.”
Rituximab
Biosimilar (PF-05280586) by Pfizer:
D. Thomas and colleagues of Pfizer presented the following
study [#2372]: “Comparison Of Proposed Biosimilar PF-05280586 With Rituximab:
Nonclinical and Phase I Clinical Assessments.” Conclusion: “PF-05280586 showed
in vitro structural and functional similarity to rituximab-EU. PF-05280586 and
rituximab appear to be well tolerated in nonclinical and clinical studies.
These results support the development of PF-05280586 as a proposed biosimilar
to rituximab.”
Infliximab
Biosimilar (CT-P13) by Celltrion:
Dae-Hyun Yoo and colleagues, most working for Celltrion,
presented the following study [#2392]: “Impact Of CT-P13 and Originator
Infliximab Treatment On Quality Of Life Derived From The Health Assessment
Questionnaire (HAQ) and Short-Form 36 (SF-36) From a Randomized, Double-Blind
Trial In Patients With Active RA.” Conclusion: “Treatment with infliximab
improved physical function as assessed by HAQ in patients with moderate to
severe physical disability which was sustained over a one year interval. These
data support the comparability with respect to improvement in physical function
of CT-P13 and INX in patients with active RA.”
Most
advanced candidates are the infliximab and rituximab biosimilars by Celltrion. Quite
strange that Pfizer is also working on a biosimilar of rituximab, but is still
far behind, which also applies to the etanercept biosimilar of Novartis.
I’ve just
checked my notebook, no further information.
So we have
to wait for EMEA and FDA to move.
PS. If you hear
something about biosimilars being introduced to the market elsewhere, please
let us know.
Links:
Biosimilars
at the 2013 EULAR Meeting in Madrid http://rheumatologe.blogspot.de/2013/07/biosimilars-after-eular-2013.html
Thank you Lothar. This is recent article about Latin America; Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases. http://www.dovepress.com/articles.php?article_id=11869
ReplyDeleteSome countries have already approved SBPs. Mexico, Chile, Ecuador, Bolivia, and Peru market SBPs of rituximab, and Colombia markets an SBP of etanercept. The advent of SBPs is definitely beneficial. Safety and efficacy must be ensured following clear and comprehensive regulations. They are not essentially biosimilars , some are approved. Clinical efficacy is ok in my own experience with the one in Colombia. Main task. Concerns about long term follow up. Learning and following.
Thank you, Carlo. One of the main obstacles in Germany will be the decision-making committee (GBA - Gemeinsamer Bundesausschuss). In their belief biosimilars should be bioidentical. I hope that they will do a little research befor it comes to decision making.
DeleteSame discussion here and worldwide I believe.
Delete