Where are the rituximab biosimilars? The
patents on Rituxan or MabThera already have expired in Europe about three and a
half years ago and in the US this September. Gabionline lists 23 rituximab
biosimilar candidates at different stages. For instance Reditux has already
been approved for the Indian market a long time ago. What’s keeping others from
entering the markets?
There has been a study on Celltrion’s
CT-P10 at the 2016 ACR Annual Meeting. Chang-Hee Suh and colleagues presented
[#1634]: “Pharmacokinetics and Safety of Three Formulations of Rituximab
(CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in
Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled
Trial over 24 Weeks”. Conclusions : “Pharmacokinetic equivalence was
demonstrated in terms of AUC0-last [area under the serum concentration-time
curve from time zero to the last measurable concentration], AUC0-inf [AUC from
time zero extrapolated to infinity] and Cmax [maximum concentration after the
second infusion] in the comparisons of CT-P10 to US-RTX [US-sourced innovator
rituximab], CT-P10 to EU-RTX [EU-sourced innovator rituximab], and US-RTX to
EU-RTX in RA patients. In addition, comparable safety profiles were observed
among the 3 treatment groups.”
A second evaluation by Dae-Hyun Yoo and
colleagues came under the title [#1635]: “Efficacy and Safety of CT-P10,
Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with
Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24
Weeks”. Conclusion: “CT-P10 showed highly similar efficacy, PD
[pharmacodynamics] and safety profiles to reference products up to 24 weeks.”
A third abstract by Eugeniy Nasonov and
colleagues brings us to interchangeability [#1639]: “Interchangeability of
Innovator Rituximab and Its Biosimilar: Results from International Controlled
Comparative 1-Year Study in Patients with Active Rheumatoid Arthritis”.
Conclusion: “BCD-020 is highly similar to innovator rituximab in terms of
efficacy, safety and immunogenicity. 1-year data show that switching between
products does not affect treatment outcomes.” BCD-020 has already been approved
in Russia in 2014 as AcellBia.
EMA has accepted GP2013, a rituximab
biosimilar, for approval process in May 2016.
As of November 2016 Amgen is still
recruiting for a phase 3 study on ABP798.
Boehringer stopped clinical development
for its rituximab biosimilar BI 695500 in October 2015. Teva and Samsung also
halted clinical development of their biosimilar rituximab candidates TL011 and
SAIT101.
The list of 23 rituximab biosimilar
candidates quickly dwindles if you consider the US and EU as markets. Most
probably we’ll see an approval of CT-P10 and GP2013 in the near future. I don’t
see an improvement of medical care, but I see possibilities for down pricing in
the high end of anti-rheumatic drugs.
Links:
Suh CH,
Berrocal Kasay A, Chalouhi El-Khouri E, Miranda P, Bozic Majstorovic L, Jeka S,
Hrycaj P, Rekalov D, Wiland P, Krause A, Szombati I, Mihailova A, Hospodarskyy
I, Piotrowski M, Kwon SR, Lee EY, Yoo DH, Park W, Shim SC, Lee SJ, Kwon TS.
Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10,
US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients
with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial
over 24 Weeks [abstract]. Arthritis
Rheumatol. 2016; 68 (suppl 10).
http://acrabstracts.org/abstract/pharmacokinetics-and-safety-of-three-formulations-of-rituximab-ct-p10-us-sourced-innovator-rituximab-and-eu-sourced-innovator-rituximab-in-patients-with-rheumatoid-arthritis-results-from-phase-3-r/.
Accessed December 20, 2016.
Yoo DH, Bozic Majstorovic L, Berrocal Kasay A,
Chalouhi El-Khouri E, Irazoque-Palazuelos F, Cons Molina F, Miranda P,
Shesternya P, Medina-Rodriguez FG, Wiland P, Jeka S, Garmish O, Hrycaj P,
Rekalov D, Fomina N, Zisman D, Park YB, Kang YM, Suh CH, Shim SC, Lee SJ, Lee
SY, Park W. Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and
Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3
Randomized Controlled Trial over 24 Weeks [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10).
http://acrabstracts.org/abstract/efficacy-and-safety-of-ct-p10-rituximab-biosimilar-candidate-and-innovator-rituximab-in-patients-with-rheumatoid-arthritis-results-from-phase-3-randomized-controlled-trial-over-24-weeks/.
Accessed December 20, 2016.
Nasonov E,
Mazurov V, Plaksina T, Nesmeyanova O, Knyazeva L, Eremeeva A, Chernyaeva E,
Ivanov R. Interchangeability of Innovator Rituximab and Its Biosimilar: Results
from International Controlled Comparative 1-Year Study in Patients with Active
Rheumatoid Arthritis [abstract]. Arthritis
Rheumatol. 2016; 68 (suppl 10).
http://acrabstracts.org/abstract/interchangeability-of-innovator-rituximab-and-its-biosimilar-results-from-international-controlled-comparative-1-year-study-in-patients-with-active-rheumatoid-arthritis/.
Accessed December 20, 2016.
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