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Positive results for infliximab and trastuzumab biosimilars Posted 13/07/2018

Celltrion Healthcare (Celltrion) and Samsung Bioepis have both announced positive results for their infliximab and trastuzumab biosimilars, respectively.

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 1 June 2018 that additional one-year follow-up study results for its trastuzumab biosimilar (SB3) ‘demonstrates the long-term safety profile of SB3’.

Patients with human epidermal growth factor receptor positive (HER2+) early breast cancer were randomly assigned to receive eight cycles of SB3 or reference trastuzumab (TRZ) in neoadjuvant setting concurrently with chemotherapy. Patients then underwent surgery, followed by 10 cycles of adjuvant SB3 or TRZ. After completion of therapy, 367 patients (SB3, n = 186; TRZ, n = 181) consented to participate in a five-year follow-up study. The median follow-up duration from initiation of study treatment was 30.1 months in SB3 and 30.2 months in TRZ.

Throughout the additional one-year treatment-free follow-up period, the study results showed low incidence of cardiac safety events and no statistically significant difference in survival results compared to TRZ in the SB3 treatment group.

Ontruzant (SB3) was approved in Europe in November 2017 [1] and Samfenet (SB3) was approved in Korea in November 2017 [2]. Samsung Bioepis also submitted SB3 to the US Food and Drug Administration (FDA) for approval in December 2017 [3].

Then on 5 June 2018, South Korean biotechnology company Celltrion announced that data had shown that the subcutaneous (SC) administration of its infliximab biosimilar (CT‑P13) was comparable in terms of efficacy and safety with intravenous (IV) administration of CT-P13 (Remsima/Inflectra) up to Week 30 in patients with active Crohn’s disease (CD).

The open-label, randomized, controlled, phase I study aimed to find the optimal dose of CT‑P13 SC by establishing pharmacokinetic (PK) comparability to CT‑P13 IV dosing. The study also evaluated the efficacy and safety of CT‑P13 SC over the first 30 weeks in patients with active CD compared to that of CT‑P13 IV.

Patients with active CD were randomly assigned into four cohorts for the study; one group receiving CT‑P13 IV (5 mg/kg, Weeks 6, 14, 22 and 30) and the other three receiving different bi-weekly doses of CT‑P13 SC (120/180/240 mg). The 30-week results from the study showed comparable efficacy of CT‑P13 SC to CT‑P13 IV with a similar rate of clinical remissions and changes from baseline of Crohn’s Disease Activity Index (CDAI), CDAI‑70 and CDAI‑100 scores. The safety profiles observed for CT‑P13 SC after randomization were also comparable to CT‑P13 IV. PK and PD modelling on the results suggested a similar dosing of CT‑P13 SC to CT‑P13 IV in active CD.

Celltrion received approval for the IV formulation of CT‑P13 as Remsima/Inflectra in Europe in September 2013 [4] and as Ixifi in the US in December 2017 [5].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant
2. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and trastuzumab biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-trastuzumab-biosimilars-approved-in-South-Korea
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts applications for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-applications-for-adalimumab-and-trastuzumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Ixifi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Ixifi

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Source: Celltrion, Samsung Bioepis

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