PMID- 37304488
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230928
IS  - 0971-4502 (Print)
IS  - 0974-0449 (Electronic)
IS  - 0971-4502 (Linking)
VI  - 39
IP  - 3
DP  - 2023 Jul
TI  - Efficacy and Safety of Biosimilar Romiplostim Versus Innovator Romiplostim in 
      Patients with Chronic Immune Thrombocytopenia.
PG  - 435-441
LID - 10.1007/s12288-022-01602-5 [doi]
AB  - Romiplostim is a Food and Drug Administration (FDA)-approved therapy for immune 
      thrombocytopenia (ITP). Biosimilar is a biological product that has no clinical 
      meaningful difference from an existing FDA-approved reference product. It has a 
      potential of lowering health-care-related cost. Biosimilar of romiplostim can be 
      made available to patients with ITP at a low cost and can be beneficial in 
      providing the best therapy. Thus, the efficacy and safety of biosimilar 
      romiplostim (ENZ110) was compared with innovator romiplostim (Nplate) with 
      respect to platelet response in patients with chronic ITP. This was a 
      prospective, multicenter, randomized, and double-blind clinical trial. Patients 
      with chronic ITP, aged 18-65 years, were enrolled in a study and were randomized 
      to receive either ENZ110 or Nplate in a 3:1 ratio for a treatment period of 
      12 weeks, respectively. After completion of the treatment period, the patients 
      were followed-up for one week to evaluate the platelet response and to monitor 
      the adverse events (AEs). Over the duration of 12 weeks, platelet response 
      of > 50 x 10(9)/L was achieved in 85.3% patients treated with ENZ110 and in 75.0% 
      patients treated with Nplate in per protocol population. In intent-to-treat 
      population, 83.8% patients with ENZ110 and 76.9% patients with Nplate achieved a 
      platelet response of > 50 x 10(9)/L. In the ENZ110 group, 111 AEs were recorded 
      in 66.7% patients, while 18 AEs were reported in 61.5% patients in the Nplate 
      group. The study demonstrated non-inferiority with comparable efficacy and safety 
      between biosimilar romiplostim and innovator romiplostim in patients with chronic 
      ITP. Trial registration number and date of registration: CTRI/2019/04/018614.
CI  - (c) The Author(s) 2022, corrected publication 2023.
FAU - Chandrakala, S
AU  - Chandrakala S
AD  - Seth G. S. Medical College and KEM Hospital, Mumbai, India. GRID: grid.414807.e. 
      ISNI: 0000 0004 1766 8840
FAU - Toshniwal, Manoj
AU  - Toshniwal M
AD  - Ishwar Institute of Health Care, Aurangabad, India.
FAU - Halvawala, Mitesh
AU  - Halvawala M
AD  - Nirmal Hospital Pvt Ltd, Surat, India.
FAU - Padwal, Namita
AU  - Padwal N
AD  - LTMMC and General Hospital, Sion, India.
FAU - Sidharthan, Neeraj
AU  - Sidharthan N
AD  - Amrita Institute of Medical Sciences, Kochi, India. GRID: grid.427788.6. ISNI: 
      0000 0004 1766 1016
FAU - Malhotra, Pankaj
AU  - Malhotra P
AD  - Postgraduate Institute of Medical Education and Research, Chandigarh, India. 
      GRID: grid.415131.3. ISNI: 0000 0004 1767 2903
FAU - Prashantha, B
AU  - Prashantha B
AD  - Kasturba Medical College (KMC) Hospital, Mangalore, India. GRID: grid.465547.1. 
      ISNI: 0000 0004 1765 924X
FAU - Ballikar, Riya
AU  - Ballikar R
AD  - Criticare Hospital and Research Institute, Nagpur, India.
FAU - Shah, Sandip
AU  - Shah S
AD  - Hemato-Oncology Clinic, Ahmedabad, India.
FAU - Apte, Shashikant
AU  - Apte S
AD  - Sahyadri Super Specialty Hospital, Pune, India.
FAU - Viswanathan, T Kasi
AU  - Viswanathan TK
AD  - Meenakshi Mission Hospital and Research Centre, Madurai, India. GRID: 
      grid.415244.2. ISNI: 0000 0004 1767 7915
FAU - Ramanan, Vijay
AU  - Ramanan V
AD  - Grant Medical Foundation Ruby Hall Clinic, Pune, India. GRID: grid.419353.9. 
      ISNI: 0000 0004 1805 9940
FAU - Sharma, Akhilesh
AU  - Sharma A
AD  - Medical Affairs Department, Alkem Laboratories Limited, Alkem House, Senapati 
      Bapat Marg,Lower Parel, Mumbai, India. GRID: grid.497415.a. ISNI: 0000 0004 1766 
      7602
FAU - Pawar, Dattatray
AU  - Pawar D
AD  - Medical Affairs Department, Alkem Laboratories Limited, Alkem House, Senapati 
      Bapat Marg,Lower Parel, Mumbai, India. GRID: grid.497415.a. ISNI: 0000 0004 1766 
      7602
FAU - Pawar, Roshan
AU  - Pawar R
AD  - Medical Affairs Department, Alkem Laboratories Limited, Alkem House, Senapati 
      Bapat Marg,Lower Parel, Mumbai, India. GRID: grid.497415.a. ISNI: 0000 0004 1766 
      7602
FAU - Shahavi, Vinayaka
AU  - Shahavi V
AD  - Medical Affairs Department, Alkem Laboratories Limited, Alkem House, Senapati 
      Bapat Marg,Lower Parel, Mumbai, India. GRID: grid.497415.a. ISNI: 0000 0004 1766 
      7602
LA  - eng
PT  - Journal Article
DEP - 20221115
PL  - India
TA  - Indian J Hematol Blood Transfus
JT  - Indian journal of hematology & blood transfusion : an official journal of Indian 
      Society of Hematology and Blood Transfusion
JID - 9425818
PMC - PMC10247600
OTO - NOTNLM
OT  - Adverse event
OT  - Biosimilar romiplostim
OT  - Efficacy endpoint
OT  - Immune thrombocytopenia
COIS- Conflicts of interestNone.
EDAT- 2023/06/12 06:42
MHDA- 2023/06/12 06:43
PMCR- 2022/11/15
CRDT- 2023/06/12 04:10
PHST- 2022/07/12 00:00 [received]
PHST- 2022/10/18 00:00 [accepted]
PHST- 2023/06/12 06:43 [medline]
PHST- 2023/06/12 06:42 [pubmed]
PHST- 2023/06/12 04:10 [entrez]
PHST- 2022/11/15 00:00 [pmc-release]
AID - 1602 [pii]
AID - 10.1007/s12288-022-01602-5 [doi]
PST - ppublish
SO  - Indian J Hematol Blood Transfus. 2023 Jul;39(3):435-441. doi: 
      10.1007/s12288-022-01602-5. Epub 2022 Nov 15.