Wednesday, January 15, 2014

Biosimilars at the 2013 ACR Meeting in San Diego

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.


Biosimilars at the 2013 EULAR Meeting in Madrid


  1. Thank you Lothar. This is recent article about Latin America; Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases.
    Some 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.

    1. 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.

    2. Same discussion here and worldwide I believe.